Manager, Clinical Data Manager – Study Lead

This is a fully remote position, open to applicants in New York.

📋 Description

• Act as the Data Management (DM) study lead and the main point of contact for clinical study teams and external collaborators.

• Supervise all DM activities throughout every phase of the trial, from study initiation to archiving.

• Deliver a high level of expertise in data management to assist clinical studies.

• Offer clear verbal and written communication along with hands-on assistance to project team members and CROs concerning eCRF and database design, data quality, and reporting on database/data quality status.

• Manage the implementation and execution of procedures for data quality review and acceptance before data analyses and/or database lock.

• Coordinate data transfers with CROs and third-party data sources, SAE/AE reconciliation, and MedDRA/WHO-DD coding.

• Aid in the transfer, locking, and archiving of study databases.

• Handle scheduling and time constraints across various projects.

• Develop recommendations for new or enhanced processes for data management and data flow.

• Document DM sponsor oversight activities from protocol review to study close-out.

⛳️ Requirements

• Bachelor's Degree or equivalent experience in Mathematics, Science, or a related field.

• A minimum of 7 years of clinical data management experience in the biotechnology, pharmaceutical, or health-related industry.

• Conduct quality review and inspection readiness tasks to ensure compliance with quarterly Inspection Readiness Review (IRR).

• Follow through on identified gaps until they are resolved, escalating issues as necessary.

• Lead and oversee all data management deliverables for assigned studies.

🏝️ Benefits

• Annual bonuses or other incentive plans.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company match.

• Health and wellness programs.

• Fitness centers.

• Insurance benefits (e.g., medical, dental, vision, life, and disability).

• Paid time off.

• Family support benefits.