Manager, Clinical Data Management

About the position The Manager, Clinical Data Management is an integral part of the Clinical Data Management (CDM) team. They are a vital team member for operational excellence in partnership with Biostatistics, Development Operations, Statistical Programming, Medical and other Global Development functions. They provide day to day oversight and project management for CDM activities, including: EDC/ePRO development, implementation, and maintenance; data review and query management; vendor management; and the coordination and execution of data deliverables.

Responsibilities

• Performs CDM activities for at least one clinical trial, ensuring all milestones are met for the study’s life cycle (start-up, maintenance, and closeout).
• Oversees and manages EDC/ePRO implementation and maintenance for their trial(s), including oversight of UAT activities.
• Oversees the data review and query management activities
• Collaborates and supports the CDM Lead for the Program in executing the program’s goals and maintaining consistency across studies.
• Is the CDM functional representative for the trial(s) at cross-functional and external (vendor/CROs) team meetings to ensure excellence in all aspects of clinical trial data acquisition, handling, and analysis.
• Performs oversight activities of CDM vendors on their trial(s).
• Ensures the trial operates in accordance with department standards and processes. Including ensuring the electronic Trial Master File (eTMF) is maintained and reviewed for the trial(s) on an ongoing basis.
• May contribute to the development of CDM processes, standards, templates.
• May collaborate on work streams and initiatives that impact the Biometrics and/or Clinical Development organizations.

Requirements

• Must have experience with the full CDM activity life cycle (start-up, maintenance, and closeout).
• Must have established knowledge and experience working with Medidata Rave EDC.
• Knowledge of MedDRA and WHODrug coding and experience overseeing coding and SAE reconciliation activities for clinical trials.
• Ability to Translate Strategic Direction into short-term goals and objectives for your trial(s).
• Ability to Inspire Innovations & Problem Solving by seeking to improve how work gets done and inspiring other team members to do the same.
• Have a strong Personal Drive and the ability to Drive Performance of others.
• Ability to demonstrate Managerial Influence – motivating and holding people accountable up, down, and across the organization (as well as vendors).
• Be a strong Decision-Maker – ensuring appropriate stakeholders are involved, all relevant data are considered, conclusions are made, and actions items are appropriately followed.
• Excellent written and oral communication skills
• Minimum BS/BA (or commensurate work experience)
• 6+ years relevant work experience with a focus on clinical data management

Nice-to-haves

• Preferably also experience working with additional modules, such as Coder, Lab Administration, Safety Gateway, RCM, TSDV and/or eCOA.
• Deep understanding of drug development and biopharmaceutical industry preferred, including all industry standards and guidance (e.g., CDISC, Data Privacy regulations)

Benefits

• performance-based annual cash bonus
• new hire equity grant
• eligibility to be considered for annual equity awards