Clark Davis Associates
Contract Data Management Team Lead
Clark Davis Associates, Jersey City, New Jersey, United States, 07390
A leading, innovative biopharmaceutical company is seeking a Data Management Lead for one or more complex clinical development projects. This role is responsible for delivering high-quality, timely clinical data management outputs that support the company’s growing development portfolio.
This is a
hybrid position
requiring a minimum of 3 days per week onsite in
Jersey City, NJ or New York, NY . (NO REMOTE APPLICANTS)
Responsibilities
Serve as the primary clinical data management lead for assigned clinical studies, ensuring alignment on data collection requirements and timelines.
Oversee end-to-end data management activities, including planning, coordination, and delivery of reliable, high-quality clinical trial data.
Manage and provide oversight of third-party vendors delivering data management services.
Lead the development, review, and approval of DM study documents, including Data Quality Management Plans, Data Validation Plans, and eCRF Completion Guidelines.
Chair Data Review meetings and drive ongoing review of trial data for quality and completeness.
Partner with cross-functional study teams, providing input on EDC setup (Veeva CDMS preferred), eCOA, RTSM, and other data collection systems.
Ensure adherence to data standards (CDASH/CDISC) and quality expectations.
Support regulatory submissions (NDA, BLA, MAA) and represent data management during audits/inspections.
Mentor and provide quality oversight for junior Data Management Leads.
Qualifications
Postgraduate degree with 8+ years or bachelor’s degree with 10+ years in Life Sciences, Biostatistics, Computer Science, or related discipline.
Proven clinical data management experience in sponsor, CRO, or vendor settings across multiple phases, indications, and geographies.
Oncology experience required.
Strong knowledge of FDA/ICH guidelines, CDASH/CDISC standards, and industry best practices.
Proficiency with EDC systems (Veeva CDMS preferred) and familiarity with eCOA, RTSM, and external data integrations.
Excellent project management, vendor oversight, and cross-functional collaboration skills.
Strong communication skills with the ability to influence across functions and levels
Seniority level Mid-Senior level
Employment type Full-time
Job function Research, Quality Assurance, and Project Management
Industries
Pharmaceutical Manufacturing
Biotechnology Research
Hospitals and Health Care
#J-18808-Ljbffr
This is a
hybrid position
requiring a minimum of 3 days per week onsite in
Jersey City, NJ or New York, NY . (NO REMOTE APPLICANTS)
Responsibilities
Serve as the primary clinical data management lead for assigned clinical studies, ensuring alignment on data collection requirements and timelines.
Oversee end-to-end data management activities, including planning, coordination, and delivery of reliable, high-quality clinical trial data.
Manage and provide oversight of third-party vendors delivering data management services.
Lead the development, review, and approval of DM study documents, including Data Quality Management Plans, Data Validation Plans, and eCRF Completion Guidelines.
Chair Data Review meetings and drive ongoing review of trial data for quality and completeness.
Partner with cross-functional study teams, providing input on EDC setup (Veeva CDMS preferred), eCOA, RTSM, and other data collection systems.
Ensure adherence to data standards (CDASH/CDISC) and quality expectations.
Support regulatory submissions (NDA, BLA, MAA) and represent data management during audits/inspections.
Mentor and provide quality oversight for junior Data Management Leads.
Qualifications
Postgraduate degree with 8+ years or bachelor’s degree with 10+ years in Life Sciences, Biostatistics, Computer Science, or related discipline.
Proven clinical data management experience in sponsor, CRO, or vendor settings across multiple phases, indications, and geographies.
Oncology experience required.
Strong knowledge of FDA/ICH guidelines, CDASH/CDISC standards, and industry best practices.
Proficiency with EDC systems (Veeva CDMS preferred) and familiarity with eCOA, RTSM, and external data integrations.
Excellent project management, vendor oversight, and cross-functional collaboration skills.
Strong communication skills with the ability to influence across functions and levels
Seniority level Mid-Senior level
Employment type Full-time
Job function Research, Quality Assurance, and Project Management
Industries
Pharmaceutical Manufacturing
Biotechnology Research
Hospitals and Health Care
#J-18808-Ljbffr