Senior Manager, Clinical Data Management

Jobgether; United States; On-site; USD 140,000 - 196,000; Full time

Benefits offered by this job

Base salary range $140,000–$196,000

Annual bonus eligibility

Equity compensation

Competitive benefits

Job summary

Jobgether in the United States seeks a Senior Manager, Clinical Data Management to lead DM activities across studies from start-up to database lock. You will provide strategic and hands-on oversight of data quality, database development, testing, data review, and vendor execution, coordinating with CROs and internal teams to ensure inspection-ready data.

The role requires 7+ years in clinical data management, strong Medidata Rave experience, and a proven ability to drive data quality, timelines,

Qualifications

• Bachelor’s degree or higher in Life Sciences or related field; advanced degree preferred.
• 7+ years clinical data management experience in pharma/biotech/CRO.
• Hands-on Medidata Rave, eCOA, RTSM experience.
• Ability to create, run, review Medidata Rave reports and listings.
• Experience testing database builds and UAT scripts.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Excellent communication and stakeholder management skills.

Responsibilities

• Lead DM strategies and timelines for assigned studies.
• Review DMPs, DVPs, edit checks, eCRF specs, and database build docs.
• Oversee Medidata Rave builds, eCRFs, edit checks, workflows, reports.
• Plan and document testing, defect tracking, UAT retesting.
• Manage data review, query management, external data reconciliation, and database lock activities.
• Monitor data quality, study metrics, timelines; identify risks early.
• Collaborate with cross-functional teams and CROs to communicate progress.
• Review CRO financials to support budget and timeline.
• Foster relationships and share best practices across programs.
• Identify opportunities to improve DM processes, tools, and templates.

Skills

Medidata Rave EDC

eCOA

RTSM

ICH-GCP

Communication

Organization

Risk management

Influence without authority

Spotfire

CDISC

Education

Bachelor’s degree in Life Sciences/Health Sciences/CS

Advanced degree preferred

Tools

Medidata Rave

Spotfire

Job description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Clinical Data Management based in United States.

This role offers the opportunity to lead clinical data management activities across one or more studies or programs, from study start-up through database lock. You will provide strategic and hands‑on oversight of data quality, database development, testing, data review, and vendor execution. Working closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, CROs, and other partners, you will help ensure reliable and inspection‑ready clinical data. The role combines technical expertise with cross‑functional leadership, requiring strong judgment and the ability to manage evolving priorities. You will also contribute to improving data management standards, processes, tools, and best practices across clinical programs. This is a high‑impact opportunity for an experienced professional who values patient‑focused execution, operational excellence, and data quality.

Accountabilities

• Serve as the lead data manager for assigned clinical studies and programs, establishing study‑specific data management strategies, timelines, and deliverables.
• Review and approve key documentation, including Data Management Plans, Data Validation Plans, edit check specifications, eCRF specifications, and database build documentation.
• Provide hands‑on oversight of Medidata Rave EDC database builds, including eCRFs, edit checks, custom functions, workflows, reports, and listings.
• Plan, execute, and document testing of database builds, eCRFs, edit checks, derivations, and system functionality, including defect assessment, resolution tracking, and UAT retesting.
• Lead data review, query management, external data reconciliation, and database lock activities while overseeing CRO and vendor deliverables.
• Monitor data quality, study metrics, and timelines to identify risks early and support external data integrations, transfer specifications, reconciliation, and inspection readiness.
• Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, CROs, and external vendors to communicate progress, risks, decisions, and timelines.
• Review CRO financial reports, change notifications, and data management expenses to support scope, budget, and timeline management.
• Build productive relationships across internal teams and external partners, navigating challenging situations with professionalism and a solutions‑oriented mindset.
• Identify opportunities to improve data management processes, standards, tools, and templates, and share best practices across clinical programs.
• Ensure day‑to‑day decisions align with study priorities, patient safety, data quality, compliance requirements, and broader program objectives.

Requirements

• Bachelor’s degree in Life Sciences, Health Sciences, Computer Science, or a related discipline; an advanced degree is preferred.
• 7+ years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry.
• Hands‑on experience with Medidata Rave EDC, eCOA, and RTSM.
• Demonstrated ability to create, run, review, and interpret Medidata Rave reports and listings for data review, cleaning, reconciliation, and oversight.
• Experience testing clinical database builds, UAT scripts, edit checks, eCRFs, and database changes, including defect documentation and retesting.
• Strong understanding of database design, edit checks, data review, query management, external data reconciliation, and database lock processes.
• Strong knowledge of ICH‑GCP and applicable clinical research regulatory requirements.
• Experience reviewing CRO study finance reports, change notifications, and data management expenses.
• Excellent written, verbal, and interpersonal communication skills, with the ability to work effectively with both technical and non‑technical stakeholders.
• Strong organizational and prioritization skills, with the ability to manage multiple studies, competing deadlines, changing requirements, and time‑sensitive deliverables.
• Demonstrated ownership, accountability, follow‑through, and attention to detail across study deliverables.
• Ability to operate effectively in a fast‑paced, high‑pressure environment while maintaining quality, compliance, and sound judgment.
• Strong problem‑solving and risk‑management skills, with the ability to make timely, risk‑based decisions in ambiguous situations.
• Ability to influence stakeholders and drive accountability across internal teams and external partners without direct authority.
• Familiarity with Spotfire or similar data visualization and analytics tools is preferred.
• Experience in a small to mid‑sized biotechnology environment is preferred.
• Familiarity with CDISC standards, risk‑based data review methodologies, and external vendor data integrations is a plus.

Benefits

• Base salary range of $140,000–$196,000 per year.
• Annual bonus eligibility.
• Equity compensation.
• Competitive benefits package.
• Opportunity to lead clinical data management activities across clinical‑stage programs.
• Cross‑functional collaboration with clinical, statistical, medical, safety, and external development teams.
• Opportunity to contribute to data management process improvements, standards, tools, and operational excellence.
• Environment focused on patient‑centred execution, data quality, compliance, and innovation.
• Opportunity to work within a growing biotechnology organization advancing AI‑enabled approaches to drug design and development.
• Equal employment opportunity and an inclusive workplace that values diverse perspectives and backgrounds.