Product Manager, Vice President - Regulatory Affairs

75026 Plano, Texas JPMorgan Chase

Posted today

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Job Description

You enjoy shaping the future of product innovation as a core leader, driving value for customers, guiding successful launches, and exceeding expectations. Join our dynamic team and make a meaningful impact by delivering high-quality products that resonate with clients.
As a Product Manager, Vice President in Deposits 2.0, you are an integral part of the team that innovates new product offerings and leads the end-to-end product life cycle. As a core leader, you are responsible for acting as the voice of the customer and developing profitable products that provide customer value. Utilizing your deep understanding of how to get a product off the ground, you guide the successful launch of products, gather crucial feedback, and ensure top-tier client experiences. With a strong commitment to scalability, resiliency, and stability, you collaborate closely with cross-functional teams to deliver high-quality products that exceed customer expectations. You will dive head-first into FDIC Part 370 regulatory compliance while also focused on modernizing our critical systems and lead development for platform functionality that calculates firm wide deposit insurance as prescribed by FDIC Part 370.
**Job responsibilities**
+ Develops a product strategy and product vision that delivers value to customers.
+ Manages discovery efforts and market research to uncover customer solutions and integrate them into the product roadmap.
+ Owns, maintains, and develops a product backlog that enables development to support the overall strategic roadmap and value proposition.
+ Builds the framework and tracks the product's key success metrics such as cost, feature and functionality, risk posture, and reliability.
+ Lead execution of Scrum teams within the FDIC Area Product Group throughout the agile software development lifecycle (gather/write business requirements, translate into stories, working E2E testing, launch, defect management).
+ Drive solutions across the organization; working with various lines of businesses, design, legal, operations, finance, and Agile technology teams to prioritize, deliver the FDIC compliance and platform modernization roadmap.
+ Pore over data, regulatory guidance and FAQs and use all the key insights to create compelling solutions and influence internal stakeholders.
+ Continuously seek to find a meaningful balance between user business objectives and technical feasibility, while managing the product delivery timeline.
+ Manage work in a highly organized, flexible manner, while staying focused on critical scope. Work in a global, organizationally complex, fast-paced and cross-functional environment.
+ Create and maintain product roadmaps that align to the product vision. Synthesize large amounts of information in order to inform and make decisions quickly, take risks, course-correct and adapt, and constantly iterate on your approach.
+ Lead a team of 4+ Product Managers engaged in the FDIC Part 370 regulatory compliance development and platform modernization
**Required qualifications, capabilities, and skills**
+ 5+ years of experience or equivalent expertise in product management or a relevant domain area.
+ Advanced knowledge of the product development life cycle, design, and data analytics.
+ Proven ability to lead product life cycle activities including discovery, ideation, strategic development, requirements definition, and value management.
+ BS/BA degree or equivalent experience.
+ Excellent communication and interpersonal skills.
+ Experience with agile delivery and quarterly increment planning.
+ Leader of collaborative scrum events (backlog refinement, sprint planning, sprint review and sprint retrospectives).
+ Proficient in JIRA.
**Preferred qualifications, capabilities, and skills**
+ Demonstrated prior experience working in a highly matrixed, complex organization
Chase is a leading financial services firm, helping nearly half of America's households and small businesses achieve their financial goals through a broad range of financial products. Our mission is to create engaged, lifelong relationships and put our customers at the heart of everything we do. We also help small businesses, nonprofits and cities grow, delivering solutions to solve all their financial needs.
We offer a competitive total rewards package including base salary determined based on the role, experience, skill set and location. Those in eligible roles may receive commission-based pay and/or discretionary incentive compensation, paid in the form of cash and/or forfeitable equity, awarded in recognition of individual achievements and contributions. We also offer a range of benefits and programs to meet employee needs, based on eligibility. These benefits include comprehensive health care coverage, on-site health and wellness centers, a retirement savings plan, backup childcare, tuition reimbursement, mental health support, financial coaching and more. Additional details about total compensation and benefits will be provided during the hiring process.
We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. We also make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as mental health or physical disability needs. Visit our FAQs for more information about requesting an accommodation.
Equal Opportunity Employer/Disability/Veterans
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Product Manager, Vice President - Regulatory Affairs

75023 Plano, Texas JPMorgan Chase Bank, N.A.

Posted 19 days ago

Job Viewed

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Job Description

Permanent
You enjoy shaping the future of product innovation as a core leader, driving value for customers, guiding successful launches, and exceeding expectations. Join our dynamic team and make a meaningful impact by delivering high-quality products that resonate with clients.

As a Product Manager, Vice President in Deposits 2.0, you are an integral part of the team that innovates new product offerings and leads the end-to-end product life cycle. As a core leader, you are responsible for acting as the voice of the customer and developing profitable products that provide customer value. Utilizing your deep understanding of how to get a product off the ground, you guide the successful launch of products, gather crucial feedback, and ensure top-tier client experiences. With a strong commitment to scalability, resiliency, and stability, you collaborate closely with cross-functional teams to deliver high-quality products that exceed customer expectations. You will dive head-first into FDIC Part 370 regulatory compliance while also focused on modernizing our critical systems and lead development for platform functionality that calculates firm wide deposit insurance as prescribed by FDIC Part 370.

Job responsibilities

  • Develops a product strategy and product vision that delivers value to customers.
  • Manages discovery efforts and market research to uncover customer solutions and integrate them into the product roadmap.
  • Owns, maintains, and develops a product backlog that enables development to support the overall strategic roadmap and value proposition.
  • Builds the framework and tracks the product's key success metrics such as cost, feature and functionality, risk posture, and reliability.
  • Lead execution of Scrum teams within the FDIC Area Product Group throughout the agile software development lifecycle (gather/write business requirements, translate into stories, working E2E testing, launch, defect management).
  • Drive solutions across the organization; working with various lines of businesses, design, legal, operations, finance, and Agile technology teams to prioritize, deliver the FDIC compliance and platform modernization roadmap.
  • Pore over data, regulatory guidance and FAQs and use all the key insights to create compelling solutions and influence internal stakeholders.
  • Continuously seek to find a meaningful balance between user business objectives and technical feasibility, while managing the product delivery timeline.
  • Manage work in a highly organized, flexible manner, while staying focused on critical scope. Work in a global, organizationally complex, fast-paced and cross-functional environment.
  • Create and maintain product roadmaps that align to the product vision. Synthesize large amounts of information in order to inform and make decisions quickly, take risks, course-correct and adapt, and constantly iterate on your approach.
  • Lead a team of 4+ Product Managers engaged in the FDIC Part 370 regulatory compliance development and platform modernization

Required qualifications, capabilities, and skills

  • 5+ years of experience or equivalent expertise in product management or a relevant domain area.
  • Advanced knowledge of the product development life cycle, design, and data analytics.
  • Proven ability to lead product life cycle activities including discovery, ideation, strategic development, requirements definition, and value management.
  • BS/BA degree or equivalent experience.
  • Excellent communication and interpersonal skills.
  • Experience with agile delivery and quarterly increment planning.
  • Leader of collaborative scrum events (backlog refinement, sprint planning, sprint review and sprint retrospectives).
  • Proficient in JIRA.

Preferred qualifications, capabilities, and skills

  • Demonstrated prior experience working in a highly matrixed, complex organization

Chase is a leading financial services firm, helping nearly half of America's households and small businesses achieve their financial goals through a broad range of financial products. Our mission is to create engaged, lifelong relationships and put our customers at the heart of everything we do. We also help small businesses, nonprofits and cities grow, delivering solutions to solve all their financial needs.

We offer a competitive total rewards package including base salary determined based on the role, experience, skill set and location. Those in eligible roles may receive commission-based pay and/or discretionary incentive compensation, paid in the form of cash and/or forfeitable equity, awarded in recognition of individual achievements and contributions. We also offer a range of benefits and programs to meet employee needs, based on eligibility. These benefits include comprehensive health care coverage, on-site health and wellness centers, a retirement savings plan, backup childcare, tuition reimbursement, mental health support, financial coaching and more. Additional details about total compensation and benefits will be provided during the hiring process.

We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. We also make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as mental health or physical disability needs. Visit our FAQs for more information about requesting an accommodation.

Equal Opportunity Employer/Disability/Veterans

Apply Now

Product Manager, Vice President - Regulatory Affairs

75023 Plano, Texas JPMorgan Chase Bank, N.A.

Posted 26 days ago

Job Viewed

Tap Again To Close

Job Description

Permanent
You enjoy shaping the future of product innovation as a core leader, driving value for customers, guiding successful launches, and exceeding expectations. Join our dynamic team and make a meaningful impact by delivering high-quality products that resonate with clients.

As a Product Manager, Vice President in Deposits 2.0, you are an integral part of the team that innovates new product offerings and leads the end-to-end product life cycle. As a core leader, you are responsible for acting as the voice of the customer and developing profitable products that provide customer value. Utilizing your deep understanding of how to get a product off the ground, you guide the successful launch of products, gather crucial feedback, and ensure top-tier client experiences. With a strong commitment to scalability, resiliency, and stability, you collaborate closely with cross-functional teams to deliver high-quality products that exceed customer expectations. You will dive head-first into FDIC Part 370 regulatory compliance while also focused on modernizing our critical systems and lead development for platform functionality that calculates firm wide deposit insurance as prescribed by FDIC Part 370.

Job responsibilities

  • Develops a product strategy and product vision that delivers value to customers.
  • Manages discovery efforts and market research to uncover customer solutions and integrate them into the product roadmap.
  • Owns, maintains, and develops a product backlog that enables development to support the overall strategic roadmap and value proposition.
  • Builds the framework and tracks the product's key success metrics such as cost, feature and functionality, risk posture, and reliability.
  • Lead execution of Scrum teams within the FDIC Area Product Group throughout the agile software development lifecycle (gather/write business requirements, translate into stories, working E2E testing, launch, defect management).
  • Drive solutions across the organization; working with various lines of businesses, design, legal, operations, finance, and Agile technology teams to prioritize, deliver the FDIC compliance and platform modernization roadmap.
  • Pore over data, regulatory guidance and FAQs and use all the key insights to create compelling solutions and influence internal stakeholders.
  • Continuously seek to find a meaningful balance between user business objectives and technical feasibility, while managing the product delivery timeline.
  • Manage work in a highly organized, flexible manner, while staying focused on critical scope. Work in a global, organizationally complex, fast-paced and cross-functional environment.
  • Create and maintain product roadmaps that align to the product vision. Synthesize large amounts of information in order to inform and make decisions quickly, take risks, course-correct and adapt, and constantly iterate on your approach.

Required qualifications, capabilities, and skills

  • 5+ years of experience or equivalent expertise in product management or a relevant domain area.
  • Advanced knowledge of the product development life cycle, design, and data analytics.
  • Proven ability to lead product life cycle activities including discovery, ideation, strategic development, requirements definition, and value management.
  • BS/BA degree or equivalent experience.
  • Excellent communication and interpersonal skills.
  • Experience with agile delivery and quarterly increment planning.
  • Leader of collaborative scrum events (backlog refinement, sprint planning, sprint review and sprint retrospectives).
  • Proficient in JIRA.

Preferred qualifications, capabilities, and skills
  • Demonstrated prior experience working in a highly matrixed, complex organization

Chase is a leading financial services firm, helping nearly half of America's households and small businesses achieve their financial goals through a broad range of financial products. Our mission is to create engaged, lifelong relationships and put our customers at the heart of everything we do. We also help small businesses, nonprofits and cities grow, delivering solutions to solve all their financial needs.

We offer a competitive total rewards package including base salary determined based on the role, experience, skill set and location. Those in eligible roles may receive commission-based pay and/or discretionary incentive compensation, paid in the form of cash and/or forfeitable equity, awarded in recognition of individual achievements and contributions. We also offer a range of benefits and programs to meet employee needs, based on eligibility. These benefits include comprehensive health care coverage, on-site health and wellness centers, a retirement savings plan, backup childcare, tuition reimbursement, mental health support, financial coaching and more. Additional details about total compensation and benefits will be provided during the hiring process.

We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. We also make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as mental health or physical disability needs. Visit our FAQs for more information about requesting an accommodation.

Equal Opportunity Employer/Disability/Veterans

Apply Now

Regulatory Affairs Specialist II, Dangerous Goods Transportation

75219 Dallas, Texas ThermoFisher Scientific

Posted 26 days ago

Job Viewed

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Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Overview:** The Regulatory Affairs Specialist II is responsible for ensuring compliance with hazardous material regulations and serving as a subject matter expert in hazardous material classification. This role requires in-depth knowledge of Department of Transportation (DOT), International Air Transport Association (IATA), and International Maritime Dangerous Goods (IMDG) regulations.
**Location:**
This is an onsite role available in 5 locations across the US. Residency near Pittsburgh, PA, Nazareth, PA, Suwanee, GA, Florence, KY or Dallas, TX. Relocation assistance is not provided.
**Key Responsibilities:**
+ Perform transportation classifications for the sale of products, ensuring compliance with relevant regulations.
+ Provide expert support on hazardous material shipping.
+ Support ongoing sales and regulatory operations for the CCG organization through additional project work as needed.
+ Review catalog and non-catalog items as part of the new product introduction process.
+ Track process metrics and conduct statistical analysis.
+ Solve problems and implement process improvements.
+ Drive continuous improvement by focusing on root causes and implementing countermeasures to prevent dangerous goods frustrated shipments.
+ Manage relationships with CCG locations to ensure compliance in their shipping activities.
**Additional Responsibilities:**
+ Conduct audits to ensure compliance with hazardous material regulations.
+ Collaborate with cross-functional teams to address and resolve compliance issues.
**Qualifications:**
+ Expertise in DOT, IATA, and IMDG regulations.
+ Strong understanding of hazardous material classification and transportation.
+ Proven experience in developing and coordinating compliance policies.
+ Excellent project management skills to support various hazardous material initiatives
**Skills and Proficiencies:**
+ Strong analytical and problem-solving skills.
+ Excellent communication and interpersonal skills.
+ Ability to work independently and as part of a team.
+ Diligent with a strong focus on accuracy and compliance.
+ Proficiency in using compliance management software and tools.
**Education and Experience:**
+ Bachelor's degree required.
+ Minimum of 5 years of experience in hazardous material compliance and transportation.
+ Certification in hazardous material handling and transportation is preferred.
Thermo Fisher Scientific is an EEO/Affirmative Action 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.
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Supervisor Clinical Research

75026 Plano, Texas Baylor Scott & White Health

Posted 25 days ago

Job Viewed

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Job Description

**About Us**
Here at Baylor Scott & White Health we promote the well-being of all individuals, families, and communities. Baylor Scott and White is the largest not-for-profit healthcare system in Texas that empowers you to live well.
Our Core Values are:
+ We serve faithfully by doing what's right with a joyful heart.
+ We never settle by constantly striving for better.
+ We are in it together by supporting one another and those we serve.
+ We make an impact by taking initiative and delivering exceptional experience.
**Benefits**
Our benefits are designed to help you live well no matter where you are on your journey. For full details on coverage and eligibility, visit the Baylor Scott & White Benefits Hub to explore our offerings, which may include:
+ Immediate eligibility for health and welfare benefits
+ 401 (k) savings plan with dollar-for-dollar match up to 5%
+ Tuition Reimbursement
+ PTO accrual beginning Day 1Note: Benefits may vary based upon position type and/or level
**Job Summary**
The Clinical Research Supervisor oversees daily supervision of Clinical Research staff. This position develops, negotiates, and monitors budgets for funded research projects. It also facilitates the implementation of clinical research projects and ensures quality and timely completion.
**Essential Functions of the Role**
+ Writes and assists in the development of proposals, grants, contracts, and budgets for the department.
+ Assists in developing new protocols and materials from study sponsors. Provides input to Principal Investigators and management on clinical and research issues to establish financial and clinical feasibility.
+ Assists various PIs, through delegated authority, in conducting clinical trials per federal, state, and institutional guidelines.
+ Prepares initial project submissions, amendment notifications, SAE reports, continuing review reports, and other reports for the IRB. Reviews staff-prepared submissions to ensure they meet established standards.
+ Oversees case report form completion by staff for all studies. Assists in coordinating audits by study sponsor monitors. Monitors assigned Clinical Research funds.
+ Orientates, trains, supervises, and evaluates Clinical Research staff. Encourages growth through complex responsibilities and education programs. Coordinates project assignments for staff.
+ Establishes and maintains good relations with the public, patients, and staff; promotes the department's research programs.
+ Monitors communication with the IRB, Food and Drug Administration (FDA), and other applicable regulatory agencies.
**Key Success Factors**
+ Research certification or other certifications per specialty area preferred.
+ Basic Life Support (BLS) per department requirements.
+ Proven written and oral communication skills.
+ Proven computer skills, including Microsoft Office, Excel, and PowerPoint.
+ Ability to manage time impressible projects in order to meet deadlines.
+ Ability to establish and maintain effective working relationships.
+ Excellent leadership skills.
**Belonging Statement**
We believe that all people should feel welcomed, valued, and supported.
**QUALIFICATIONS**
+ EDUCATION - Bachelor's or 4 years of work experience above the minimum qualification
+ EXPERIENCE - 2 Years of Experience
As a health care system committed to improving the health of those we serve, we are asking our employees to model the same behaviours that we promote to our patients. As of January 1, 2012, Baylor Scott & White Health no longer hires individuals who use nicotine products. We are an equal opportunity employer committed to ensuring a diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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Clinical Research Coord 1

75026 Plano, Texas Baylor Scott & White Health

Posted 11 days ago

Job Viewed

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Job Description

**About Us**
Here at Baylor Scott & White Health we promote the well-being of all individuals, families, and communities. Baylor Scott and White is the largest not-for-profit healthcare system in Texas that empowers you to live well.
Our Core Values are:
+ We serve faithfully by doing what's right with a joyful heart.
+ We never settle by constantly striving for better.
+ We are in it together by supporting one another and those we serve.
+ We make an impact by taking initiative and delivering exceptional experience.
**Benefits**
Our benefits are designed to help you live well no matter where you are on your journey. For full details on coverage and eligibility, visit the Baylor Scott & White Benefits Hub to explore our offerings, which may include:
+ Eligibility on day 1 for all benefits
+ Dollar-for-dollar 401(k) match, up to 5%
+ Debt-free tuition assistance, offering access to many no-cost and low-cost degrees, certificates and more
+ Immediate access to time off benefits
At Baylor Scott & White Health, your well-being is our top priority.
Note: Benefits may vary based on position type and/or level
**Job Summary**
The Clinical Research Coordinator 1 helps Principal Investigators (PI) with clinical trials. This includes all trial phases, from pre-study to closure, following federal, state, and Institutional guidelines. This position will learn to assist on complex studies and seek guidance from senior roles when needed.
**Essential Functions of the Role**
+ Implements various protocols for assigned research projects with appropriate departments. Interacts with PIs, clinical managers, and supervisors.
+ Creates, facilitates, or executes various project workflows based on clinical trial protocol needs. Examples include providing in-service education for healthcare professionals and working with Pharmacy to ensure smooth project flow.
+ Ensures appropriate billing mechanisms are in place for research charges. Requires familiarity with research study budgets. Provides feedback on budgets for new clinical trials.
+ Performs research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.
+ Partners and coordinates with regulatory compliance. Prepares Institutional Review Board (IRB) materials for protocol amendments. Submits Investigational New Drug (IND) Safety forms. Ensures all study documents are complete. Retains records per federal, state, and institutional standards.
+ Obtains knowledge of departmental functions through reading literature, attending workshops, seminars and conferences and participating in professional organizations.
+ Conducts and coordinates study-monitoring visits. Conducts audits and quality checks to ensure research studies are accurate, consistent, and have integrity.
**Key Success Factors**
+ Research certification or other certifications per specialty area preferred.
+ Proven written and oral communication skills.
+ Exceptional computer skills, including Microsoft Office.
+ Ability to manage time reactive projects in order to meet deadlines.
+ Exceptional ability to establish and maintain effective working relationships.
**Belonging Statement**
We believe that all people should feel welcomed, valued and supported, and that our workforce should be reflective of the communities we serve.
**QUALIFICATIONS**
+ EDUCATION - Bachelor's or 4 years of work experience above the minimum qualification
+ EXPERIENCE - Less than 1 Year of Experience
As a health care system committed to improving the health of those we serve, we are asking our employees to model the same behaviours that we promote to our patients. As of January 1, 2012, Baylor Scott & White Health no longer hires individuals who use nicotine products. We are an equal opportunity employer committed to ensuring a diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
View Now

Senior Clinical Research Scientist

75201 Dallas, Texas $115000 Annually WhatJobs

Posted today

Job Viewed

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Job Description

full-time
Our client is searching for a highly accomplished Senior Clinical Research Scientist to contribute to groundbreaking research and development in the pharmaceutical sector, based in Dallas, Texas, US . This role involves the design, execution, and interpretation of clinical trials, focusing on the development of novel therapeutics. You will play a critical part in developing clinical trial protocols, selecting investigative sites, managing study budgets, and ensuring compliance with regulatory guidelines (FDA, EMA, GCP). The Senior Scientist will collaborate closely with cross-functional teams, including biostatistics, data management, regulatory affairs, and medical affairs, to ensure the successful progression of clinical programs. Expertise in a specific therapeutic area and a strong understanding of drug development processes are essential. This position offers the opportunity to influence the strategic direction of clinical research initiatives and contribute to bringing life-changing medications to patients.

Key Responsibilities:
  • Designing and developing clinical trial protocols that meet scientific, medical, and regulatory requirements.
  • Overseeing the execution of clinical studies, ensuring adherence to timelines, budgets, and quality standards.
  • Interpreting clinical data, performing statistical analysis, and preparing comprehensive study reports.
  • Collaborating with investigators, clinical research associates (CRAs), and site staff to ensure effective study conduct.
  • Engaging with regulatory authorities to prepare submissions and address queries.
  • Contributing to the development of regulatory submission documents (e.g., INDs, NDAs).
  • Providing scientific and clinical expertise to internal teams and external stakeholders.
  • Evaluating new drug candidates and therapeutic strategies for potential clinical development.
  • Staying abreast of scientific literature, industry trends, and competitive landscape in relevant therapeutic areas.
  • Ensuring all clinical trial activities comply with Good Clinical Practice (GCP) and other applicable regulations.
The ideal candidate will hold a Ph.D. or M.D. in a life science, medical, or related field, with a minimum of 7 years of experience in clinical research within the pharmaceutical or biotechnology industry. Demonstrated experience in clinical trial design and management, data analysis, and regulatory submissions is required. Excellent scientific judgment, analytical skills, and written and verbal communication abilities are essential. Experience in a specific therapeutic area such as oncology, cardiology, or neurology is a significant advantage. This role requires a proactive individual with strong leadership potential and the ability to manage complex projects effectively.
Apply Now
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About the latest Pharmaceutical services Jobs in Dallas !

Senior Clinical Research Associate

75201 Dallas, Texas $95000 Annually WhatJobs

Posted 1 day ago

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Job Description

full-time
Our client, a leading entity in the pharmaceutical sector, is seeking a highly experienced and dedicated Senior Clinical Research Associate (CRA) to join their dynamic team. This pivotal role will be based in Dallas, Texas, US , with a hybrid work arrangement offering flexibility between home and office. The Senior CRA will be instrumental in the planning, execution, and monitoring of clinical trials, ensuring adherence to protocols, GCP, and regulatory requirements. You will be responsible for site selection, initiation, monitoring, and close-out visits, as well as maintaining effective communication with investigative sites, study sponsors, and internal project teams. Key responsibilities include ensuring data integrity and accuracy, identifying and resolving site issues, and contributing to the development of study-related documents such as protocols, case report forms (CRFs), and informed consent forms. The ideal candidate will possess a strong understanding of clinical trial processes, regulatory landscapes (FDA, EMA, ICH-GCP), and risk-based monitoring strategies. This position requires an individual with excellent analytical, problem-solving, and communication skills, capable of managing multiple priorities in a fast-paced environment. You will also be expected to mentor junior CRAs and contribute to process improvements within the clinical operations department. A bachelor's degree in a life science or related field is required, with advanced degrees preferred. A minimum of 5 years of direct CRA experience in the pharmaceutical or biotechnology industry is essential. Strong knowledge of electronic data capture (EDC) systems and clinical trial management systems (CTMS) is highly desirable. If you are a motivated and detail-oriented professional looking for a challenging and rewarding opportunity to advance your career in clinical research, we encourage you to apply. Join us in making a significant impact on patient health by contributing to groundbreaking pharmaceutical advancements.
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Senior Clinical Research Scientist

75201 Dallas, Texas $135000 Annually WhatJobs

Posted 2 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is actively seeking a Senior Clinical Research Scientist to join their innovative team. This hybrid position, based in **Dallas, Texas, US**, combines remote flexibility with essential in-office collaboration. The Senior Clinical Research Scientist will play a pivotal role in the design, execution, and interpretation of clinical trials for novel therapeutics. Responsibilities include developing clinical trial protocols, evaluating investigational drug products, analyzing clinical data, and ensuring compliance with regulatory guidelines (e.g., FDA, EMA). You will collaborate with cross-functional teams, including R&D, regulatory affairs, and medical affairs, to drive study progress and ensure scientific rigor. The ideal candidate will possess a Ph.D. or Master's degree in a relevant scientific field (e.g., Pharmacology, Biology, Medicine) with extensive experience in clinical drug development. Strong understanding of biostatistics, clinical trial design principles, and pharmacokinetics/pharmacodynamics is essential. Excellent written and verbal communication skills are required to present findings and interact with internal and external stakeholders, including investigators and regulatory agencies. This role demands a proactive approach, critical thinking, and the ability to manage multiple projects in a dynamic environment. You will contribute to shaping the therapeutic strategy and advancing life-saving medicines. This is an exciting opportunity for a seasoned scientist to make a significant impact on patient health and to grow within a globally recognized organization. The position offers a competitive salary, comprehensive benefits, and opportunities for professional development in a cutting-edge research setting.
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Senior Clinical Research Associate

75201 Dallas, Texas $95000 Annually WhatJobs

Posted 2 days ago

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Job Description

full-time
Our client is seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to join their dynamic pharmaceutical team in Dallas, Texas, US . This role involves overseeing clinical trials, ensuring adherence to protocols, and maintaining data integrity. The Senior CRA will be responsible for site selection, initiation, monitoring, and close-out visits. You will work closely with investigators and site staff to ensure all study activities are conducted in accordance with Good Clinical Practice (GCP), applicable regulations, and study protocols. Key responsibilities include managing a portfolio of sites, troubleshooting site issues, and ensuring timely data collection and query resolution. The ideal candidate will have a strong understanding of drug development processes and regulatory requirements. You will also be involved in training and mentoring junior CRAs, contributing to the overall success of the clinical research department. This position offers a hybrid work arrangement, blending in-office collaboration with remote flexibility, allowing for a healthy work-life balance. We are looking for individuals with exceptional communication, organizational, and problem-solving skills. A Bachelor's degree in a life science, nursing, or related field is required, along with a minimum of 5 years of progressive experience in clinical research monitoring. Advanced degrees are a plus. Thorough knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial processes is essential. The ability to travel to clinical sites as needed (up to 50%) is also a requirement for this role. Join a team dedicated to advancing healthcare through innovative research and development in a supportive and collaborative environment. The company is committed to fostering professional growth and offers competitive compensation and benefits.
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  50. local_hospital Military & Public Safety
  51. local_hospital Mining
  52. medical_services Nursing
  53. local_gas_station Oil & Gas
  54. biotech Pharmaceutical
  55. checklist_rtl Project Management
  56. shopping_bag Purchasing
  57. home_work Real Estate
  58. person_search Recruitment Consultancy
  59. store Retail
  60. point_of_sale Sales
  61. science Scientific Research & Development
  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
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