4,525 Clinical Data Manager jobs in the United States

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**Clinical Data Manager**
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
+ Career development with an international company where you can grow the career you dream of.
+ Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
+ An excellent retirement savings plan with a high employer contribution
+ Tuition reimbursement, the Freedom 2 Save ( student debt program, and FreeU ( education benefit - an affordable and convenient path to getting a bachelor's degree.
+ A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
+ A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
**The Opportunity**
The Clinical Data Manager is responsible for performing data management tasks within defined established processes throughout the life cycle of the study including startup, conduct and reporting phases. The Clinical Data Manager is also responsible for the development, maintenance and training of peers in the applicable processes. This role is critical to the successful collection, reporting and analysis of clinical trial data as well as the mentorship of junior team members.
This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday.
**What You'll Work On**
+ Assist in translation of clinical study requirements into trial Casebook.
+ Develop and maintain Data Management Plans (DMPs) for clinical trials.
+ Develop edit check specifications for the automated cleaning of data management practices and procedures (SOPs, Work Instructions), including identifying and recommending solutions for technology issues.
+ Conduct user acceptance testing of clinical study databases, reports, study notifications and database customizations
+ Develop study specific data listings and ensure data accuracy and integrity
+ Identify and resolve data discrepancies and inconsistencies.
+ Identify opportunities for improvement and proposed solutions, develop procedures and train to new processes.
+ Mentor junior team members in the roles and responsibilities of the Clinical Data Management Analyst.
**Required Qualifications**
+ B.S. in Computer Science, Life Sciences or Technical Field.
+ Equivalent combination of education and work experience will be considered.
+ Minimum 5 years in clinical or medical or research setting.
**Preferred Qualifications**
+ Expert in data collection best practices for clinical trials.
+ Expert knowledge of global clinical operations.
+ Experience utilizing electronic data capture systems (EDC) and eTMF systems.
+ Knowledge of industry-standard data analysis and reporting software, such as SAS and SQL.
+ Intermediate to advanced therapy specific knowledge of anatomy, physiology, pathophysiology, therapy and device.
+ Intermediate to advanced medical knowledge related to common medical histories, medical terminology, diagnostics (imaging, laboratory), and medications (class, dose, route).
+ Excellent attention to detail with problem-solving and analytical skills.
+ Certified Clinical Data Manager (CCDM) or equivalent.
Apply Now ( more about our health and wellness benefits, which provide the security to help you and your family live full lives:** ( your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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**Divisional Information**
Medical Devices
General Medical Devices:
Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
Diabetes
We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.
The base pay for this position is $86,700.00 - $173,300.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

Job Description

Job Description

Job Title: Clinical Data Manager – Data Integrity & Analysis

Own the data. Shape the science.

About RDI

RDI is a CRO purpose-built for diagnostics. Since 2008, we’ve completed over 200 trials supporting some of the largest IVD companies in the world. Our mission is to get better tests to market — faster — with cleaner data, smarter tools, and zero nonsense.

We work at the intersection of research, tech, and regulatory strategy. If you care about meaningful data, and want to see your work shape real-world decisions, you’ll feel right at home here.

The Role

We’re looking for a Clinical Data Manager who does more than clean data — you think critically about how it's structured, how it will be analyzed, and whether it will hold up to regulatory scrutiny.

You’ll sit between clinical operations and biostatistics, owning the entire flow of subject- and sample-level data. You’ll build eCRFs, validate inputs, spot errors others miss, and help shape how that data is ultimately analyzed and presented.

If you’ve ever wanted to be both the person who finds the bad data and the person who can explain why it matters — this is that role.

Why This Role?

• You’ll have end-to-end ownership : from raw inputs to regulatory-ready datasets
• You’ll work across teams — clinical, lab, tech, and regulatory — with visibility and voice
• Your work won’t just live in spreadsheets. It will show up in FDA filings, strategic meetings, and patient-facing diagnostics

Key Responsibilities

• Build and optimize electronic case report forms (eCRFs) to simplify physician data entry and reduce protocol deviations
• Review, clean, and validate large clinical datasets (subject metadata, lab results, demographics, etc.)
• Flag inconsistencies, errors, and outliers with precision and context
• Format data to support downstream analysis (e.g., standardization, categorical formatting, units, date logic)
• Support basic statistical reporting (e.g., inclusion criteria tracking, diversity metrics, confidence intervals, ROC)
• Collaborate with our regulatory and science team to ensure final datasets support submission claims
• Partner with Salesforce developers and EDC platforms to improve the usability of our paperless trial systems
• Create reports that help us track site enrollment, sample quality, and trial performance in real time

Ready to own the data — and the outcome?

Join us and build something that actually matters.

Requirements

• 3+ years in clinical data management or diagnostics data analysis
• Strong Excel skills, plus familiarity with EDC platforms (Castor, Cloudbyz, REDCap, etc.)
• Exposure to basic biostatistics (even if not a statistician): sensitivity/specificity, AUC, stratification, etc.
• Ability to write queries, troubleshoot messy data, and explain your logic to both devs and scientists
• A mindset for structure, logic, and accuracy — you question the data before trusting it
• Bonus if you’ve worked with R, SAS, or Python to run analyses or QA data
• Even better if you’ve touched submissions to FDA or worked in regulated diagnostics

Ready to own the data — and the outcome?

Join us and build something that actually matters.

Benefits

• Health Care Plan (Medical, Dental & Vision)

• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)

Principal Clinical Data Manager
Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.
Who Are You?
We are seeking a highly experienced and strategic Principal Clinical Data Manager to contribute to the transformation of data management. This role is pivotal in reengineering core clinical data management workflows, developing comprehensive SOPs and interactive process flows, and ensuring seamless execution across all phases of clinical trials. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Clinical Data Manager you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. You will be part of the team focused on this transformation initiative with support from both Cytel and our Client. This is an exciting time to be a part of this new program.
**As a Principal Clinical Data Manager, your responsibilities will include:**
+ **Process Reengineering & Oversight:**
+ Collaborate on the redesign of end-to-end data management processes to support internal execution, including study start-up, maintenance, and close-out.
+ Evaluate and revise existing procedures to align with internal capabilities, ensuring efficiency, compliance, and scalability.
+ **SOP & Process Flow Development:**
+ Develop and implement SOPs and interactive process maps that provide a comprehensive overview of the data management lifecycle.
+ Ensure documentation reflects best practices and supports cross-functional understanding and training.
+ **Functional Area Ownership:**
+ Oversee the reengineering of critical data management functions, including:
+ Study Set-Up
+ EDC Build and Maintenance
+ Data Cleaning and Query Management
+ Local Lab and External Data Handling
+ Clinical Coding
+ SAE Reconciliation
+ Blinding Procedures
+ Site Close-Out and Database Lock
+ DM Metrics and Clean Patient Tracker
+ **Cross-Functional Collaboration:**
+ Partner with Data Management leaders and cross-functional workstream groups to define deliverables and ensure alignment with broader program goals.
+ Provide subject matter expertise and strategic input to support project planning and execution.
+ **Quality & Compliance:**
+ Ensure all processes and deliverables meet regulatory requirements and internal quality standards.
+ Support audit readiness and continuous improvement initiatives.
+ **Following project completion may transition into a hands-on Clinical Data Manager Role, where responsibilities may include but not be limited to:**
+ Represents data management function on the clinical trial working group, ensuring aligned expectations for all data related deliverables, especially in support of key decision points and regulatory submissions.
+ Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
+ Contributes influential leadership in collaboration with other client stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
+ Ensures achievement of major data management deliverables and milestones in coordination with other functions including Clinical Operations, Statistical Programming and Statistics.
+ Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
+ Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
+ Bachelor's degree in Life Sciences, Health Informatics, or related field
+ 10+ years of progressive experience in clinical data management, with significant experience in a leadership or principal-level role.
+ Proven expertise in process development, SOP writing, and cross-functional collaboration.
+ Strong knowledge of EDC systems, CDISC standards, and regulatory requirements.
+ Excellent communication, organizational, and problem-solving skills.
An equivalent combination of education and experience may be considered in lieu of stated requirements.
Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Principal Clinical Data Manager
Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.
Who Are You?
We are seeking a highly experienced and strategic Principal Clinical Data Manager to contribute to the transformation of data management. This role is pivotal in reengineering core clinical data management workflows, developing comprehensive SOPs and interactive process flows, and ensuring seamless execution across all phases of clinical trials. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Clinical Data Manager you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. You will be part of the team focused on this transformation initiative with support from both Cytel and our Client. This is an exciting time to be a part of this new program.
**As a Principal Clinical Data Manager, your responsibilities will include:**
+ **Process Reengineering & Oversight:**
+ Collaborate on the redesign of end-to-end data management processes to support internal execution, including study start-up, maintenance, and close-out.
+ Evaluate and revise existing procedures to align with internal capabilities, ensuring efficiency, compliance, and scalability.
+ **SOP & Process Flow Development:**
+ Develop and implement SOPs and interactive process maps that provide a comprehensive overview of the data management lifecycle.
+ Ensure documentation reflects best practices and supports cross-functional understanding and training.
+ **Functional Area Ownership:**
+ Oversee the reengineering of critical data management functions, including:
+ Study Set-Up
+ EDC Build and Maintenance
+ Data Cleaning and Query Management
+ Local Lab and External Data Handling
+ Clinical Coding
+ SAE Reconciliation
+ Blinding Procedures
+ Site Close-Out and Database Lock
+ DM Metrics and Clean Patient Tracker
+ **Cross-Functional Collaboration:**
+ Partner with Data Management leaders and cross-functional workstream groups to define deliverables and ensure alignment with broader program goals.
+ Provide subject matter expertise and strategic input to support project planning and execution.
+ **Quality & Compliance:**
+ Ensure all processes and deliverables meet regulatory requirements and internal quality standards.
+ Support audit readiness and continuous improvement initiatives.
+ **Following project completion may transition into a hands-on Clinical Data Manager Role, where responsibilities may include but not be limited to:**
+ Represents data management function on the clinical trial working group, ensuring aligned expectations for all data related deliverables, especially in support of key decision points and regulatory submissions.
+ Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
+ Contributes influential leadership in collaboration with other client stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
+ Ensures achievement of major data management deliverables and milestones in coordination with other functions including Clinical Operations, Statistical Programming and Statistics.
+ Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
+ Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
+ Bachelor's degree in Life Sciences, Health Informatics, or related field
+ 10+ years of progressive experience in clinical data management, with significant experience in a leadership or principal-level role.
+ Proven expertise in process development, SOP writing, and cross-functional collaboration.
+ Strong knowledge of EDC systems, CDISC standards, and regulatory requirements.
+ Excellent communication, organizational, and problem-solving skills.
An equivalent combination of education and experience may be considered in lieu of stated requirements.
Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Principal Clinical Data Manager
Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.
Who Are You?
We are seeking a highly experienced and strategic Principal Clinical Data Manager to contribute to the transformation of data management. This role is pivotal in reengineering core clinical data management workflows, developing comprehensive SOPs and interactive process flows, and ensuring seamless execution across all phases of clinical trials. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Clinical Data Manager you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. You will be part of the team focused on this transformation initiative with support from both Cytel and our Client. This is an exciting time to be a part of this new program.
**As a Principal Clinical Data Manager, your responsibilities will include:**
+ **Process Reengineering & Oversight:**
+ Collaborate on the redesign of end-to-end data management processes to support internal execution, including study start-up, maintenance, and close-out.
+ Evaluate and revise existing procedures to align with internal capabilities, ensuring efficiency, compliance, and scalability.
+ **SOP & Process Flow Development:**
+ Develop and implement SOPs and interactive process maps that provide a comprehensive overview of the data management lifecycle.
+ Ensure documentation reflects best practices and supports cross-functional understanding and training.
+ **Functional Area Ownership:**
+ Oversee the reengineering of critical data management functions, including:
+ Study Set-Up
+ EDC Build and Maintenance
+ Data Cleaning and Query Management
+ Local Lab and External Data Handling
+ Clinical Coding
+ SAE Reconciliation
+ Blinding Procedures
+ Site Close-Out and Database Lock
+ DM Metrics and Clean Patient Tracker
+ **Cross-Functional Collaboration:**
+ Partner with Data Management leaders and cross-functional workstream groups to define deliverables and ensure alignment with broader program goals.
+ Provide subject matter expertise and strategic input to support project planning and execution.
+ **Quality & Compliance:**
+ Ensure all processes and deliverables meet regulatory requirements and internal quality standards.
+ Support audit readiness and continuous improvement initiatives.
+ **Following project completion may transition into a hands-on Clinical Data Manager Role, where responsibilities may include but not be limited to:**
+ Represents data management function on the clinical trial working group, ensuring aligned expectations for all data related deliverables, especially in support of key decision points and regulatory submissions.
+ Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
+ Contributes influential leadership in collaboration with other client stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
+ Ensures achievement of major data management deliverables and milestones in coordination with other functions including Clinical Operations, Statistical Programming and Statistics.
+ Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
+ Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
+ Bachelor's degree in Life Sciences, Health Informatics, or related field
+ 10+ years of progressive experience in clinical data management, with significant experience in a leadership or principal-level role.
+ Proven expertise in process development, SOP writing, and cross-functional collaboration.
+ Strong knowledge of EDC systems, CDISC standards, and regulatory requirements.
+ Excellent communication, organizational, and problem-solving skills.
An equivalent combination of education and experience may be considered in lieu of stated requirements.
Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Principal Clinical Data Manager
Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.
Who Are You?
We are seeking a highly experienced and strategic Principal Clinical Data Manager to contribute to the transformation of data management. This role is pivotal in reengineering core clinical data management workflows, developing comprehensive SOPs and interactive process flows, and ensuring seamless execution across all phases of clinical trials. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Clinical Data Manager you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. You will be part of the team focused on this transformation initiative with support from both Cytel and our Client. This is an exciting time to be a part of this new program.
**As a Principal Clinical Data Manager, your responsibilities will include:**
+ **Process Reengineering & Oversight:**
+ Collaborate on the redesign of end-to-end data management processes to support internal execution, including study start-up, maintenance, and close-out.
+ Evaluate and revise existing procedures to align with internal capabilities, ensuring efficiency, compliance, and scalability.
+ **SOP & Process Flow Development:**
+ Develop and implement SOPs and interactive process maps that provide a comprehensive overview of the data management lifecycle.
+ Ensure documentation reflects best practices and supports cross-functional understanding and training.
+ **Functional Area Ownership:**
+ Oversee the reengineering of critical data management functions, including:
+ Study Set-Up
+ EDC Build and Maintenance
+ Data Cleaning and Query Management
+ Local Lab and External Data Handling
+ Clinical Coding
+ SAE Reconciliation
+ Blinding Procedures
+ Site Close-Out and Database Lock
+ DM Metrics and Clean Patient Tracker
+ **Cross-Functional Collaboration:**
+ Partner with Data Management leaders and cross-functional workstream groups to define deliverables and ensure alignment with broader program goals.
+ Provide subject matter expertise and strategic input to support project planning and execution.
+ **Quality & Compliance:**
+ Ensure all processes and deliverables meet regulatory requirements and internal quality standards.
+ Support audit readiness and continuous improvement initiatives.
+ **Following project completion may transition into a hands-on Clinical Data Manager Role, where responsibilities may include but not be limited to:**
+ Represents data management function on the clinical trial working group, ensuring aligned expectations for all data related deliverables, especially in support of key decision points and regulatory submissions.
+ Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
+ Contributes influential leadership in collaboration with other client stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
+ Ensures achievement of major data management deliverables and milestones in coordination with other functions including Clinical Operations, Statistical Programming and Statistics.
+ Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
+ Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
+ Bachelor's degree in Life Sciences, Health Informatics, or related field
+ 10+ years of progressive experience in clinical data management, with significant experience in a leadership or principal-level role.
+ Proven expertise in process development, SOP writing, and cross-functional collaboration.
+ Strong knowledge of EDC systems, CDISC standards, and regulatory requirements.
+ Excellent communication, organizational, and problem-solving skills.
An equivalent combination of education and experience may be considered in lieu of stated requirements.
Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Principal Clinical Data Manager
Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.
Who Are You?
We are seeking a highly experienced and strategic Principal Clinical Data Manager to contribute to the transformation of data management. This role is pivotal in reengineering core clinical data management workflows, developing comprehensive SOPs and interactive process flows, and ensuring seamless execution across all phases of clinical trials. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Clinical Data Manager you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. You will be part of the team focused on this transformation initiative with support from both Cytel and our Client. This is an exciting time to be a part of this new program.
**As a Principal Clinical Data Manager, your responsibilities will include:**
+ **Process Reengineering & Oversight:**
+ Collaborate on the redesign of end-to-end data management processes to support internal execution, including study start-up, maintenance, and close-out.
+ Evaluate and revise existing procedures to align with internal capabilities, ensuring efficiency, compliance, and scalability.
+ **SOP & Process Flow Development:**
+ Develop and implement SOPs and interactive process maps that provide a comprehensive overview of the data management lifecycle.
+ Ensure documentation reflects best practices and supports cross-functional understanding and training.
+ **Functional Area Ownership:**
+ Oversee the reengineering of critical data management functions, including:
+ Study Set-Up
+ EDC Build and Maintenance
+ Data Cleaning and Query Management
+ Local Lab and External Data Handling
+ Clinical Coding
+ SAE Reconciliation
+ Blinding Procedures
+ Site Close-Out and Database Lock
+ DM Metrics and Clean Patient Tracker
+ **Cross-Functional Collaboration:**
+ Partner with Data Management leaders and cross-functional workstream groups to define deliverables and ensure alignment with broader program goals.
+ Provide subject matter expertise and strategic input to support project planning and execution.
+ **Quality & Compliance:**
+ Ensure all processes and deliverables meet regulatory requirements and internal quality standards.
+ Support audit readiness and continuous improvement initiatives.
+ **Following project completion may transition into a hands-on Clinical Data Manager Role, where responsibilities may include but not be limited to:**
+ Represents data management function on the clinical trial working group, ensuring aligned expectations for all data related deliverables, especially in support of key decision points and regulatory submissions.
+ Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
+ Contributes influential leadership in collaboration with other client stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
+ Ensures achievement of major data management deliverables and milestones in coordination with other functions including Clinical Operations, Statistical Programming and Statistics.
+ Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
+ Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
+ Bachelor's degree in Life Sciences, Health Informatics, or related field
+ 10+ years of progressive experience in clinical data management, with significant experience in a leadership or principal-level role.
+ Proven expertise in process development, SOP writing, and cross-functional collaboration.
+ Strong knowledge of EDC systems, CDISC standards, and regulatory requirements.
+ Excellent communication, organizational, and problem-solving skills.
An equivalent combination of education and experience may be considered in lieu of stated requirements.
Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Principal Clinical Data Manager
Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.
Who Are You?
We are seeking a highly experienced and strategic Principal Clinical Data Manager to contribute to the transformation of data management. This role is pivotal in reengineering core clinical data management workflows, developing comprehensive SOPs and interactive process flows, and ensuring seamless execution across all phases of clinical trials. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Clinical Data Manager you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. You will be part of the team focused on this transformation initiative with support from both Cytel and our Client. This is an exciting time to be a part of this new program.
**As a Principal Clinical Data Manager, your responsibilities will include:**
+ **Process Reengineering & Oversight:**
+ Collaborate on the redesign of end-to-end data management processes to support internal execution, including study start-up, maintenance, and close-out.
+ Evaluate and revise existing procedures to align with internal capabilities, ensuring efficiency, compliance, and scalability.
+ **SOP & Process Flow Development:**
+ Develop and implement SOPs and interactive process maps that provide a comprehensive overview of the data management lifecycle.
+ Ensure documentation reflects best practices and supports cross-functional understanding and training.
+ **Functional Area Ownership:**
+ Oversee the reengineering of critical data management functions, including:
+ Study Set-Up
+ EDC Build and Maintenance
+ Data Cleaning and Query Management
+ Local Lab and External Data Handling
+ Clinical Coding
+ SAE Reconciliation
+ Blinding Procedures
+ Site Close-Out and Database Lock
+ DM Metrics and Clean Patient Tracker
+ **Cross-Functional Collaboration:**
+ Partner with Data Management leaders and cross-functional workstream groups to define deliverables and ensure alignment with broader program goals.
+ Provide subject matter expertise and strategic input to support project planning and execution.
+ **Quality & Compliance:**
+ Ensure all processes and deliverables meet regulatory requirements and internal quality standards.
+ Support audit readiness and continuous improvement initiatives.
+ **Following project completion may transition into a hands-on Clinical Data Manager Role, where responsibilities may include but not be limited to:**
+ Represents data management function on the clinical trial working group, ensuring aligned expectations for all data related deliverables, especially in support of key decision points and regulatory submissions.
+ Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
+ Contributes influential leadership in collaboration with other client stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
+ Ensures achievement of major data management deliverables and milestones in coordination with other functions including Clinical Operations, Statistical Programming and Statistics.
+ Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
+ Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
+ Bachelor's degree in Life Sciences, Health Informatics, or related field
+ 10+ years of progressive experience in clinical data management, with significant experience in a leadership or principal-level role.
+ Proven expertise in process development, SOP writing, and cross-functional collaboration.
+ Strong knowledge of EDC systems, CDISC standards, and regulatory requirements.
+ Excellent communication, organizational, and problem-solving skills.
An equivalent combination of education and experience may be considered in lieu of stated requirements.
Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
As the **Senior Clinical Data Manager** , you will ensure the quality and integrity of data collected in Clinical studies, the privacy of patient data, and the efficient recording and reporting of safety-related issues. As well as conduct all clinical data management functions (lead clinical study set-up, migrations, conduct/maintenance to database lock).
This is a hybrid role (office and remote blend). Selected candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days.
**How you will make an impact:**
+ Create complex metrics to identify trends in data and remediation, utilizing tools (e.g., systems, reports) to assess need for training and provide recommendations to improve data status during study conduct
+ Define and specify clinically complex data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected.
+ Lead project management activities for multiple (multi-site and multi-cohort) projects to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.
+ Develop and maintain Data Management deliverables including data management plans (DMPs), training materials and user aids in compliance with regulations
+ Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution
+ Perform Site/User Administration to allow access to the database, ensuring all users are qualified to access data base; may provide guidance on more complex access rights for users
+ Lead development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training.
+ Other incidental duties assigned by Leadership
**What you'll need (Required):**
+ Bachelor's degree and 5 years of previous related experience in clinical research including clinical data management and/or clinical data entry **OR**
+ Associate degree or equivalent in a related field and 7 years of previous related experience in clinical research including clinical data management and/or clinical data entry
+ Experience with Medidata Rave EDC (Electronic Data Capture)
**What else we look for (Preferred):**
+ Minimum of 2 years leading clinical studies combined with 5 years of relevant experience in clinical research, including roles in clinical data management and/or clinical data entry.
+ Full knowledge of protocols, DMPs, SAPs, Database Specification, and Data Validation Specification
+ Proven expertise in Microsoft Office Suite
+ Advanced Excel skills (pivot tables and formulas)
+ Microsoft Power BI
+ Project management skills and lead cross functional meetings
+ Full knowledge of processes and procedures in clinical data management
+ Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills.
+ Excellent problem-solving and critical thinking skills
+ Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects.
+ Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $106,000 to $135,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
**COVID Vaccination Requirement**
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.