Senior Manager, Clinical Data Management (Contractor)
About The Position
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. Position We are currently recruiting a Senior Manager, Clinical Data Management (Contractor) who is responsible for timely and high-quality data management deliverables supporting the Eikon portfolio. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. About You You are a highly motivated and detail-oriented clinical data management professional with a strong track record of delivering high-quality data in fast-paced clinical development environments. You bring deep hands-on expertise across end-to-end data management activities and take pride in driving accuracy, consistency, and compliance throughout the study lifecycle. You are a strong collaborator who thrives in cross-functional settings, partnering effectively with Clinical Operations, Biostatistics, Programming, and external vendors to ensure alignment and timely execution.
Requirements
- Post Graduate degree with 6+ years of experience or a Bachelor's degree with 8+ years of experience in a relevant field such as Life Sciences, Biostatistics, Computer Science, or a related discipline.
- Proven experience in clinical data management gained from working at recognized clinical data management suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic, and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
- Prior experience supporting oncology clinical trials is required.
- Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors.
- Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management.
- Strong knowledge and experience of EDC systems (Veeva CDMS preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection.
- Strong project management; Exhibits expertise in metrics analysis and reporting methodologies.
- Excellent oral and written communication skills.
- Communicate effectively with senior management and cross-functional teams.
- Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)].
- Deep knowledge of CDASH/CDISC (CDASH CRF Library implementation experience is preferred).
Responsibilities
- Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects.
- Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects.
- Responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal and external study team members.
- Provides strong quality and project oversight over third party vendor responsible for data management deliverables.
- Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, RTSM).
- Enforces data standard conventions and quality expectations for clinical data per defined processes.
- Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization.
- Chairs Data Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness.
- Represents DM on cross-functional project teams & submission Teams.
- Leads or supports the Health Authority inspections and audits.
- Provides coaching and quality oversight of junior Data Management Leads.
- Acts as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA).
- Leads/provides the relevant support to set up, validate the standard eCRF library.
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What This Job Offers
Career Level
Mid Level
