BD (Becton, Dickinson and Company) Clinical Study Manager 1 in Franklin Lakes, New Jersey
Job Description Summary
Working within the Global Clinical Development (GCD) organization, the Clinical Study Manager 1 is responsible for the planning, implementation, oversight, project management and completion of clinical trials conducted by GCD. The Study Manager 1 serves as the project lead for studies of low to moderate 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.
Working under moderate supervision and following established procedures, 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).
Interface with clinical data management and statistics in developing case report forms, managing data cleanup, and analyzing study data
Develop budget/schedule (in collaboration with Core Team and/or Portfolio Management)
Oversee site selection and training
Obtain, review and approve study documents
Maintain trial master file
Perform study execution and status reporting activities
Prepare final clinical study report and oversee study closeout activities
Manages relationships sites/PIs and other study specific vendors
Fundamental working 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 and may include basic 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.
Contacts are primarily Internal with some external providing direction to the GCD cross functional team members and vendors (if applicable) regarding the technical, protocol-specific and operational aspects of assigned studies.
Under minimal direction, 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, education and experience sufficient to contribute within local work unit with limited/general supervision preferably in the life sciences, clinical or other relevant technical areas. Advanced degree desirable (e.g., MS, MBA, PhD, MPH, PharmD, MD).
Minimum of 2 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 2 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 studies.
Knowledge of clinical trial concepts and practices, including international clinical research guidelines.
Strong client and vendor relationship management skills.
Ability to work effectively 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 LocationUSA NJ - Franklin Lakes
Additional LocationsUSA NC - Research Triangle Park
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status