Job Description Summary
Working within the Global Clinical Development (GCD) organization, the Clinical Senior Study Manager is responsible for clinical trial management of multiple studies and may be subject matter expert for a program or platform of assigned clinical studies including the planning, implementation, oversight, project management and completion of clinical trials conducted by GCD or Contract Research Organizations (CRO). The Senior Study Manager may also serve as a mentor to Associate, Study Manager 1 & Study Manager 2 levels. This role serves as the project lead for studies of moderate to high complexity from protocol development through study conduct and closeout in compliance with Good Clinical Practices, and all Global, National and Local Regulations. Reports to and collaborates with Clinical Portfolio Manager to review business requests, and evaluate or develop early plans and concepts for optimal study execution.
Works with limited occasional supervision and direction, prepares and/or reviews study-related or essential study start-up documents as they relate to the assigned clinical trials (e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
Serve as a Study Manager ensuring that the Study Management team meets or exceeds the timelines and deliverables assigned to the study team
Oversee/lead study-specific study management resources
Develop and manage group of studies for an entire business unit or large development program
Mentor Associates at the Associate Study Manager, Study Manager I and Study Manager 2 levels.
Provide critical thinking and leadership when issues arise during execution of clinical studies
Lead or contribute to continuous improvement activities/initiatives
Manages relationships with sites/PIs. other study related vendors, including CRO’s
Intermediate knowledge of established project management standards used to develop and maintain integrated project plans (scope/work packages, time/schedule, cost/material and human resource, quality, communication/escalation, risk, value) and organizes/facilitates meetings and discussions as needed.
Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff.
Adapts work package deliverables based on study scale and complexity.
Creates aggressive but achievable resource and budget forecasts and timelines.
Both internal and external contacts, providing direction to the GCD cross functional team members and vendors (if applicable) regarding the technical, protocol-specific and operational aspects of assigned studies.
Proactively identifies and manages risks and issues (including a log, mitigations, and contingencies) to ensure cost effective timely delivery of the project including escalation if needed
Plans and maintains high quality standards in order to meet compliance requirements.
All other duties as assigned
Bachelor's degree required, preferably in the life sciences, clinical or other relevant technical areas. Advanced degree desirable (e.g., MS, MBA, PhD, MPH, PharmD, MD).
Minimum of 5 years project management experience preferably using MS Project and/or recent proven success within a BD product development core/extended team.
PMP certification highly desirable.
Minimum 5 years of clinical study experience, (e.g., pharmaceutical, medical device, IVD, biotechnology, CRO) including the proven ability to oversee clinical teams in the conduct and report of multicenter, global complex studies.
Knowledge of clinical trial concepts and practices, including international clinical research guidelines.
Strong client and vendor relationship management skills.
Ability to work effectively, independently with multi-level teams, manage multiple projects and work in a fast paced and changing environment.
Demonstrated and effective interpersonal, communications and negotiation skills for a wide variety of audiences.
Ability to work effectively in a virtual environment.
Ability to travel approximately 30% of the time, US and Internationally.
Primary Work Location
USA MD - Baltimore