Eikon Therapeutics · 1 day ago
Senior Manager, Clinical Data Management
Jersey City, NJ
Full-time
Onsite
Senior Level
$152K/yr - $166K/yr
6+ years expEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology to discover novel treatments for life-threatening diseases. They are seeking a Senior Manager, Clinical Data Management who will lead data management deliverables for clinical development projects, ensuring high-quality and timely data collection and management.
BiotechnologyHealth CareLife ScienceMedical
Responsibilities
Provide 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 plan, coordinate, and deliver 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 serve as a primary point of contact for internal and external study team members
Provide strong quality and project oversight over third party vendor responsible for data management deliverables
Take a leadership role to gather content and integration requirements for EDC and closely collaborate with partners supporting other data collection systems (eCOA, External Data, RTSM). Enforce data standard conventions and quality expectations for clinical data per defined processes
Author, review/revise 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
Chair Data Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness
Represent DM on cross-functional project teams & submission teams
Lead or support the Health Authority inspections and audits
Provide coaching and quality oversight of junior Data Management Leads
Act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manage data currency throughout the trial, and perform overall monitoring DM deliverables according to the Service Level Agreement (SLA)
Lead/provide the relevant support to set up, validate the standard eCRF library
Qualification
Required
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
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
Deep knowledge of CDASH/CDISC (CDASH CRF Library implementation experience is preferred)
Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)]
Preferred
Oncology experience preferred
Veeva CDMS preferred
CDASH CRF Library implementation experience is preferred
Benefits
401k plan with company matching
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
Mental health and wellness benefits
Weeklong summer and winter holiday shutdowns
Generous paid time off and holiday policies
Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
Enhanced parental leave benefit
Daily subsidized lunch program when on-site
Company
Eikon Therapeutics
Eikon Therapeutics is a biopharmaceutical company that develops live-cell resolution microscopy and engineering for drug discovery.
201-500 employees
H1B Sponsorship
Eikon Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (19)
2023 (7)
2022 (3)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$1.12BKey Investors
The Column Group
2025-02-26Series D· $350.7M
2023-06-01Series C· $106M
2022-01-06Series B· $518M
Leadership Team
Roger Perlmutter
Chairman, President, and CEO
Michael Klobuchar
Chief Operating Officer
Recent News
General Catalyst
2025-12-26
2025-12-02
Company data provided by crunchbase