4,338 Clinical Data Manager jobs in the United States

Clinical Data Manager

Atlanta, Georgia Peachtree BioResearch Solutions

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Job Description

Job Description

Peachtree BioResearch Solutions, a Julius Clinical Company, is a global specialized full-service CRO providing highly specialized study operations teams for pharmaceutical, biotech, and medical device companies. Formed over 15 years ago by a pharma leadership team experienced in buying CRO services with the purpose of creating trusting partnerships with sponsor clients - no matter their budget. We do this by investing in people who thrive in an environment where their experience and contributions can be felt throughout the organization. It's an exciting time as we expand our global reach, while still offering a personalized approach to sponsors and delivering incredible value.

The data management group at Peachtree has been the backbone of the company since its inception. We are looking to add an experienced Clinical Data Manager (CDM) to a very high-performing team. The CDM is responsible for all data management activities associated with the acquisition, documentation, review, cleaning and processing of clinical data in clinical trials.

RESPONSIBILITIES

  • As a member of the clinical study team, relay information regarding data management status, knowledge regarding area of discipline, and timelines affecting Data Management deliverables.
  • Ensuring the Case Report Form is designed according to the Clinical Protocol, utilizing Data Standards where possible, and document deviations, if necessary.
  • Creating the Data Management Plan, Data Cleaning Plan, Quality Control Plan, and Data Management Report while ensuring consistency with the Clinical Trial Protocol and are in compliance with internal or sponsor procedures, international or national regulations and Good Clinical Practices.
  • Projecting, planning, developing, implementing and delivering quality results in a timely manner. This will require the use of facts, data, measurements and a systematic approach and is accomplished specifically by:
  • Interpreting the Clinical Protocol to ensure the accurate and efficient design of the CRF
  • Analyzing metrics surrounding the activities associated with the acquisition, documentation, review, cleaning and processing of clinical data
  • Interpreting study timelines and prioritizing workload appropriately.
  • Assisting with Clinical Data Associate activities during times of peak workload.

EXPERIENCE:

  • Clinical Data Management experience in a CRO
  • Working knowledge of medical terminology, federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices
  • Excellent communication, organization, and problem solving skills
  • Ability to work independently, as well as handle a number of diverse projects simultaneously, under tight time constraints
  • Ability to engage and demonstrate cooperative behavior to support team efforts
  • Experience in responding rapidly to changing priorities and in managing aggressive deadlines.

In addition to working with great people on high performing teams, full-time employees receive:

  • Medical, Dental, Vision, Life, Disability coverage
  • 20 days PTO + PTO rollover + 13 paid holidays
  • 401(k)

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Senior Clinical Data Manager

92604 Woodbridge, California Edwards Lifesciences

Posted 2 days ago

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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.
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Lead Clinical Data Manager

66219 Lenexa, Kansas ICON Clinical Research

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Lead Data Manager, US, Remote
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Senior Clinical Data Science Lead to join our diverse and dynamic team. As a Senior Clinical Data Science Lead at ICON, you will play a pivotal role in leading the analysis, interpretation, and management of clinical data to drive the success of our clinical trials. You will contribute to the advancement of innovative treatments and therapies by overseeing data science initiatives and ensuring data quality and integrity across studies.
**What You Will Be Doing:**
+ Lead end to end data review activities performed on a clinical trial.
+ Accountable for achieving clinical data science deliverables on-time, with high- quality and to agreed financial metrics.
+ Serve as primary point of contact for internal and external team members regarding clinical data review activities and leads these data review activities to ensure delivery of data fit for analysis.
+ Provides input into clinical system development activities and clinical risk management activities.
**Your Profile:**
+ Bachelor's degree or equivalent in Health or Science discipline, with experience in clinical research, desired.
+ Minimum of 5 years of Data Management experience (start-up to lock).
+ Clinical trials experience is required. Experience managing multiples studies at once with experience managing competing priorities is needed.
+ Oncology experience is helpful. But, not required.
+ Experience working in highly diverse teams within clinical research; cross-functional, global, multi-regional.
+ Project management skills. Must have prior experience creating timelines and managing deliverables.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
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Senior Clinical Data Manager

48201 Detroit, Michigan $100000 Annually WhatJobs

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full-time
Our client, a leading pharmaceutical research organization located in Detroit, Michigan , is seeking an experienced Senior Clinical Data Manager to oversee critical data management activities for their diverse clinical trial portfolio. This role requires a meticulous and highly organized individual with a profound understanding of data integrity, regulatory compliance, and clinical trial processes. You will be responsible for the end-to-end management of clinical trial data, including database design and setup, data validation planning and execution, data cleaning, and database lock. This position involves close collaboration with clinical operations, biostatistics, programming, and quality assurance teams to ensure high-quality, accurate, and reliable data for analysis and regulatory submissions. The Senior Clinical Data Manager will play a key role in developing and implementing data management plans, standard operating procedures (SOPs), and data management guidelines. You will also be responsible for training and mentoring junior data management staff, reviewing data management deliverables, and ensuring adherence to Good Clinical Practice (GCP) guidelines and relevant regulatory requirements (e.g., FDA, EMA). Experience with various Electronic Data Capture (EDC) systems and data management software is essential. The ideal candidate will possess exceptional problem-solving abilities, strong leadership qualities, and the capacity to manage multiple projects simultaneously within demanding timelines. A commitment to scientific rigor and patient safety is paramount. This role requires being present on-site to facilitate close collaboration with internal teams and access to company resources.
Responsibilities:
  • Lead and manage all aspects of clinical data management for assigned studies.
  • Oversee the design, development, and validation of clinical databases (e.g., EDC systems).
  • Develop and implement Data Management Plans (DMPs).
  • Define data validation procedures and critical data review processes.
  • Ensure data accuracy, completeness, and integrity throughout the trial lifecycle.
  • Manage data cleaning activities and coordinate query resolution.
  • Oversee database lock procedures and final data reconciliation.
  • Ensure compliance with GCP, regulatory requirements, and company SOPs.
  • Train, mentor, and supervise junior data management personnel.
  • Liaise with cross-functional teams, sponsors, and vendors on data-related issues.
Qualifications:
  • Bachelor's degree in Life Sciences, Computer Science, Statistics, or a related field.
  • Minimum 7 years of progressive experience in clinical data management.
  • Extensive experience with EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva Vault EDC).
  • In-depth knowledge of clinical trial processes, data standards (CDISC), and regulatory guidelines.
  • Strong understanding of database design, validation, and data quality principles.
  • Excellent leadership, project management, and problem-solving skills.
  • Proficiency in data analysis and reporting tools.
  • Ability to work effectively in a team-oriented environment.
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Senior Clinical Data Manager

90001 Los Angeles, California $160000 Annually WhatJobs

Posted 7 days ago

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full-time
Our client, a renowned pharmaceutical organization committed to advancing healthcare solutions, is actively seeking a highly experienced Senior Clinical Data Manager. This role is situated in the bustling metropolis of Los Angeles, California , and offers a flexible hybrid work arrangement, blending office collaboration with remote flexibility. You will play a critical role in ensuring the integrity, accuracy, and consistency of clinical trial data across multiple global studies. Your expertise will be crucial in managing the data lifecycle from database design and UAT to data cleaning, validation, and database lock, ensuring compliance with regulatory standards such as GCP and ICH.

As a Senior Clinical Data Manager, you will lead data management activities for complex clinical trials, oversee data management vendors, and mentor junior data management staff. Responsibilities include developing data management plans, designing case report forms (CRFs), establishing data validation specifications, and coordinating with clinical operations, biostatistics, and clinical research associates to resolve data queries promptly. The ideal candidate will possess a comprehensive understanding of clinical trial processes, database technologies (e.g., EDC systems like Medidata Rave, Oracle Clinical), and data standards (e.g., CDISC SDTM, ADaM). This is an exceptional opportunity for a seasoned professional to contribute to the development of life-saving therapies and advance their career within a leading pharmaceutical company.

Key Responsibilities:
  • Lead the planning, execution, and oversight of clinical data management activities.
  • Develop and maintain data management plans (DMPs).
  • Design and validate Electronic Data Capture (EDC) databases and CRFs.
  • Oversee data cleaning, query resolution, and data reconciliation processes.
  • Ensure adherence to GCP, ICH guidelines, and internal SOPs.
  • Manage and mentor junior data management personnel.
  • Liaise with clinical sites, CRAs, statisticians, and programming teams.
  • Perform User Acceptance Testing (UAT) for clinical databases.
  • Prepare databases for final lock and archival.

We are looking for candidates with a Bachelor's degree in a scientific or healthcare-related field, and a minimum of 7 years of experience in clinical data management within the pharmaceutical or biotechnology industry. Strong knowledge of EDC systems, clinical data standards (CDISC), and regulatory requirements is mandatory. Excellent analytical, problem-solving, and organizational skills, coupled with effective communication and leadership abilities, are essential. Join our dedicated team and contribute to impactful clinical research.
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Lead Clinical Data Manager

10001 New York, New York $130000 Annually WhatJobs

Posted 7 days ago

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full-time
Our client, a prominent pharmaceutical company, is seeking an experienced and meticulous Lead Clinical Data Manager to oversee all aspects of clinical data management for their groundbreaking research studies. This pivotal role involves leading a team of data managers, ensuring data integrity, quality, and compliance with regulatory standards (e.g., FDA, ICH). The Lead Clinical Data Manager will be responsible for the design, development, and implementation of robust data management plans, the creation of databases, data validation procedures, and the delivery of high-quality datasets for analysis.

Key Responsibilities:
  • Lead and mentor a team of clinical data managers, providing guidance and oversight.
  • Develop and maintain comprehensive Data Management Plans (DMPs) for clinical trials.
  • Oversee the design, build, and validation of clinical databases (EDC systems).
  • Define data validation and edit check specifications to ensure data accuracy and consistency.
  • Manage data cleaning activities, including query generation and resolution, in collaboration with clinical sites and monitors.
  • Ensure compliance with all applicable regulatory requirements and company SOPs.
  • Develop and implement data management metrics and reporting.
  • Oversee the transfer of clinical trial data to biostatisticians and other stakeholders.
  • Contribute to the selection and management of third-party data management vendors.
  • Participate in protocol reviews and provide input on data collection strategies.
  • Stay abreast of industry best practices and emerging technologies in clinical data management.
  • Contribute to the continuous improvement of data management processes and tools.

Qualifications:
  • Bachelor's or Master's degree in a relevant scientific field (e.g., Pharmacy, Life Sciences, Computer Science).
  • Minimum of 7 years of experience in clinical data management within the pharmaceutical or biotech industry.
  • Proven experience leading and managing a team of data managers.
  • Extensive knowledge of EDC systems (e.g., Medidata Rave, Oracle Clinical) and data management best practices.
  • Deep understanding of clinical trial processes and regulatory guidelines (GCP, ICH).
  • Strong project management and organizational skills.
  • Excellent analytical and problem-solving abilities.
  • Exceptional communication and interpersonal skills, with the ability to interact effectively with diverse stakeholders.
  • Proficiency in SQL and database management is a plus.
This role offers a hybrid work arrangement, balancing collaborative in-office work with remote flexibility, located in **New York City, New York, US**. Our client offers a competitive salary, robust benefits, and a stimulating environment for professional growth.
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Remote Clinical Data Manager

33101 Miami, Florida $80000 Annually WhatJobs

Posted 7 days ago

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full-time
Our client, a leading biopharmaceutical company, is seeking a meticulous and experienced Remote Clinical Data Manager to join their dynamic clinical operations team. This fully remote position offers a crucial role in ensuring the accuracy, completeness, and integrity of clinical trial data, which is essential for regulatory submissions and the successful development of new therapies. You will be responsible for the design, development, and management of clinical databases, establishing data management plans, and overseeing data collection and query resolution processes. Key responsibilities include developing case report forms (CRFs), designing database specifications, performing data validation checks, managing data entry, and ensuring compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements. You will collaborate closely with clinical research associates (CRAs), biostatisticians, and clinical investigators to ensure data quality throughout the clinical trial lifecycle. The ideal candidate will possess a strong understanding of clinical trial processes, data management principles, and relevant regulatory standards. Proficiency with clinical data management systems (CDMS) such as Medidata Rave, Oracle Clinical, or similar platforms is essential. Excellent analytical and problem-solving skills, meticulous attention to detail, and the ability to work independently and manage multiple projects in a remote setting are critical. A Bachelor's degree in a scientific or healthcare-related field, along with substantial experience in clinical data management, is required. Experience with therapeutic areas relevant to the company's pipeline is a plus. If you are passionate about contributing to life-saving therapies and possess the expertise to ensure high-quality clinical data in a remote environment, we encourage you to apply.

Responsibilities:
  • Manage the end-to-end clinical data management process for assigned studies.
  • Develop and implement Data Management Plans (DMPs).
  • Design and build clinical databases, including CRF design and edit check specifications.
  • Oversee data entry, data validation, and query resolution processes.
  • Ensure data accuracy, completeness, consistency, and integrity.
  • Collaborate with CRAs and clinical sites to resolve data discrepancies.
  • Liaise with biostatisticians and programming teams for data analysis and database lock.
  • Ensure compliance with GCP, FDA regulations, and other relevant guidelines.
  • Generate data management reports and metrics.
  • Participate in clinical trial team meetings and contribute data management expertise.
  • Stay current with industry best practices and technologies in clinical data management.
Qualifications:
  • Bachelor's degree in a scientific, healthcare, or related field.
  • Minimum of 3-5 years of experience in clinical data management within the pharmaceutical or biotech industry.
  • Proficiency with clinical data management systems (e.g., Medidata Rave, Oracle Clinical, SAS).
  • Strong understanding of clinical trial processes and GCP guidelines.
  • Excellent analytical, problem-solving, and organizational skills.
  • Meticulous attention to detail and commitment to data quality.
  • Ability to work independently and manage multiple projects effectively in a remote setting.
  • Strong written and verbal communication skills.
  • Experience with EDC (Electronic Data Capture) systems.
  • Familiarity with database design and validation concepts.
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Senior Clinical Data Manager #4239

94025 Menlo Park, California GRAIL

Posted 2 days ago

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Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges.
GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.
For more information, please visit grail.com .
The Senior Clinical Data Manager (CDM) will lead data management activities for one or multiple diagnostic product development studies in support of GRAIL's robust clinical development pipeline.
**Responsibilities:**
+ Work closely with GRAIL study team members to ensure that clinical data captured is complete, consistent, and accurate.
+ Perform study startup activities such as study protocol review, Clinical Data Management Plan (CDMP) development, and Electronic Data Capture (EDC) set-up, while collaborating with Clinical Technology staff to integrate with external systems.
+ Manage study conduct activities including facilitation of study team data review, documentation of data handling decisions, issuance of data queries and resolution of data discrepancies.
+ Utilize programming skills to create listings and dashboards as required by study team members.
+ Lead data locking efforts, ensuring that study team members have executed according to the CDMP.
+ Ensure that data integrity is maintained throughout the data lifecycle for sources including clinical data, external bio-specimen storage data, and data produced by ultra-deep ctDNA sequencing laboratories.
+ Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File.
+ Create/review the Data Transfer Plan with External Data Providers or collaborators.
+ Assist Director of Clinical Data Management and other GRAIL staff with developing and implementing data standards, controlled procedural documents, and software development efforts.
**Preferred Qualifications & Background:**
+ 5+ years of industry experience required in clinical data management within the pharmaceutical, biotechnology, and/or diagnostics industry in an FDA-regulated environment, with a strong track record of EDC system implementation and collaboration with study teams to ensure data quality.
+ Bachelor's degree required; advanced degree preferred. Additional coursework in programming, analytics, or related disciplines is strongly desired.
+ Experience working on IDE trials and device registries within the medical device and/or pharmaceutical industry.
+ Prior experience leading mid to large scale clinical trials and ability to support multiple projects at a given time.
+ Experience working with EDC systems.
+ Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA).
+ Strong interpersonal communication (written and verbal) and organizational skills.
+ Excellent team player with demonstrated track record of success in a cross-functional team environment. Consistent commitment to delivering on team goals with a sense of shared urgency.
+ Experience managing vendors and partnering with collaborators to deliver according to contracts and plans.
+ Familiarity with various data visualization, analytics, and reporting tools (e.g. tableau).
+ Experience programming in R, SAS is preferred.
+ Prior experience working on the sponsor side is required.
+ Molecular diagnostics industry experience preferred.
+ Experience working on developing standard operating procedures for clinical data management in collaboration with cross functional teams.
The expected, full-time, annual base pay scale for this position is $105K - $131K for Menlo Park, CA. Actual base pay will consider skills, experience, and location.
Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.
In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
GRAIL is an Equal Employment Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us ( to request accommodation. GRAIL maintains a drug-free workplace.
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Remote Senior Clinical Data Manager

28202 Charlotte, North Carolina $110000 Annually WhatJobs

Posted 4 days ago

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full-time
Our client, a cutting-edge pharmaceutical company at the forefront of medical innovation, is seeking a dedicated and experienced Senior Clinical Data Manager to join their globally distributed team. This is a fully remote position, offering the flexibility to work from anywhere within the US. You will play a pivotal role in ensuring the accuracy, completeness, and integrity of clinical trial data, which is fundamental to the development of life-saving therapies. As a Senior Clinical Data Manager, you will oversee the design, development, and implementation of clinical databases, manage data cleaning activities, and ensure compliance with regulatory standards such as CDISC, GCP, and FDA guidelines. Your expertise will guide the data management lifecycle from study startup through database lock.

Key Responsibilities:
  • Lead the development and validation of clinical databases according to study protocols and data management plans.
  • Oversee data collection, validation, and cleaning processes, ensuring data quality and integrity.
  • Develop and maintain data management documentation, including Case Report Forms (CRFs), edit specifications, and data validation plans.
  • Manage User Acceptance Testing (UAT) for databases and data management systems.
  • Liaise with clinical operations, biostatistics, and programming teams to address data-related issues and ensure timely query resolution.
  • Ensure compliance with all relevant regulatory guidelines (e.g., FDA, EMA) and internal SOPs.
  • Participate in the review of clinical study reports and contribute to data analysis and interpretation.
  • Provide technical expertise and guidance on clinical data management best practices to cross-functional teams.
  • Contribute to the continuous improvement of data management processes and systems.
  • Manage timelines and deliverables for data management activities across multiple studies.
Qualifications:
  • Bachelor's degree in a scientific discipline, computer science, or a related field. Master's degree preferred.
  • A minimum of 7 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
  • In-depth knowledge of clinical trial processes, GCP, and regulatory requirements (FDA, ICH).
  • Proficiency with clinical data management systems (e.g., Medidata Rave, Oracle Clinical, Veeva Vault EDC).
  • Experience with CDISC standards (SDTM, ADaM) is essential.
  • Strong understanding of database design, data validation, and query management.
  • Excellent analytical, problem-solving, and organizational skills.
  • Exceptional written and verbal communication abilities, with a proven ability to collaborate effectively in a remote team environment.
  • Ability to manage multiple projects simultaneously and meet strict deadlines.
This remote role requires self-discipline, proactive communication, and a strong commitment to delivering high-quality data in a virtual setting.
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Principal Clinical Data Manager - Remote

84111 Salt Lake City, Utah $130000 Annually WhatJobs

Posted 7 days ago

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full-time
Our client, a leading pharmaceutical innovator, is seeking an experienced Principal Clinical Data Manager to join their fully remote Clinical Operations team. This senior role is pivotal in ensuring the accuracy, completeness, and integrity of clinical trial data, which is essential for regulatory submissions and drug approval. The ideal candidate will possess a deep understanding of clinical data management principles, regulatory requirements (e.g., ICH GCP, FDA guidelines), and industry-standard data management systems. You will be responsible for leading data management activities across multiple clinical trials, developing data management plans, designing clinical databases, establishing data validation checks, and overseeing the data cleaning and reconciliation processes. This role involves close collaboration with clinical research associates (CRAs), biostatisticians, medical monitors, and project managers to ensure timely and high-quality data delivery. As a remote-first position, strong organizational skills, proactive communication, and the ability to work independently with minimal supervision are crucial. You will also be involved in training and mentoring junior data managers and contributing to the continuous improvement of data management processes and standards. Qualifications include a Bachelor's degree in a relevant scientific or healthcare field; a minimum of 10 years of progressive experience in clinical data management within the pharmaceutical or biotechnology industry; extensive experience with EDC (Electronic Data Capture) systems (e.g., Medidata Rave, Oracle InForm); proven expertise in developing and executing data management plans, edit checks, and data validation strategies; strong understanding of CDISC standards (SDTM, ADaM); excellent analytical, problem-solving, and communication skills; and the ability to manage multiple projects simultaneously in a fast-paced environment. Experience with database programming and statistical software is a plus.
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  63. psychology Therapy
  64. pets Veterinary
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