Manager Clinical Data Management

Experience Requirements:

At least 5 years of relevant industry experience. Project management certification (e.g. PMP) is desirable.

Key Competency Requirements:

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 (Medidata RAVE 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)]

Position Summary:

The Senior Manager, Clinical Data Management is a project leadership role considered essential to the sustainability and success of the BMS R&D pipeline. This role may report into Sr.Director, Global Data Operations Delivery, Director, CDM or Associate Director, CDM and is a full-time office-based position with flexibility to work remotely up to 50% of the time over 2 weeks.

Position Responsibilities:

Project Management and Leadership:

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, Safety Gateway). 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 Quality 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

Lead or support the Health Authority inspections and audits

Provides coaching and quality oversight of junior Data Management Leads

FSP/CRO/Vendor Oversight

May act 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)

Continuous improvement initiatives

Provides the relevant support and input to continuous improvement activities within clinical data management

Provides support for CAPA implementation as required