Job Description
Clinical Project Manager
Functional/Organizational Summary
Medical Affairs (MA) plays a critical role in new product development, including Key Opinion Leader engagement on innovative technologies;user needs, requirements, and hazard identification, all to ensure product safety and efficacy. MA also contributes significantly to post-market risk estimation criteria, risk-benefit analysis of products, Clinical Evaluation Reports, and literature searches.
Position Summary
Reporting within Specimen Management Clinical Operations Medical Affairs, the Clinical Project Manager is responsible for Human Subject Research trial management (clinical, non-clinical, and administrative functions) across multiple studies. This individual may serve as a subject matter expert for a group or platform of assigned clinical studies, including planning, implementation, oversight, project management, and completion of Human Subject Research conducted by Specimen Management (SM) Medical Affairs or a Contract Research Organization (CRO), if applicable.
As the project lead for studies of moderate to high complexity, from protocol development through study conduct and closeout, the Clinical Project Manager ensures compliance with Good Clinical Practices and all Global, National, and Local Regulations. The role collaborates with cross-functional teams, including Data Management, Statistics, and other members of the SM Medical Affairs team, to evaluate and/or develop clinical studies. This position may directly or indirectly (matrix) manage professional employees, business support, or technical staff.
Job responsibilities:
- Prepares and/or reviews study-related or essential study start-up documents as they relate to the assigned human subject research trials (e.G., Clinical Protocols, Informed Consent forms, Investigator Brochures, Monitoring Plan, and other relevant study plans and charters)
- Serves as a Sr. Clinical Project Manager ensuring that the Study Management team meets or exceeds the timelines and deliverables assigned to the study team.
- Responsible for scheduling and running study team meetings and generation of meeting minutes and other study-related documentation.
- Oversees/leads study-specific study management resources.
- Accountable for setting own work direction and completing work tasks assigned by leadership team.
- Develops and manages group of studies for an entire business unit or large development program.
- Provides critical thinking and leadership when issues arise during execution of clinical studies, including risk management and mitigation actions.
- Leads or contributes to continuous improvement activities/initiatives.
- Manages relationships with sites/PIs and 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, progress, risks, 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.
- Has accountability for good stewardship of financial resources for personal and project expenses.
- Interacts with both Internal and External contacts, providing direction to the Global Clinical Affairs (GCA) 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 escalations, as needed.
- Plans and maintains high quality standards in order to meet compliance requirements.
- Performs other duties and assignments as required.
Professional Skills & Key Competencies
- Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving.
- Demonstrated ability to juggle multiple tasks and to prioritize and schedule work to meet business needs.
- Demonstrated organizational, planning, and project management skills, including action oriented, focused urgency, and driving for result.
- Ability to be effective in complex projects with ambiguity and/or rapid change.
- Orientation for detailed work product, with emphasis on accuracy and completeness.
- Working knowledge of Good Clinical Practice, and all Global, National and Local Regulations.
Education Qualifications & Previous Experience:
- Required: Bachelor's Degree and 3-5 years in human subject research or equivalent
- Preferred: Advanced degree (MS, MBA, etc.).
- Highly preferred: Experience directly or indirectly (matrix) managing vendors, cross-functional project team members, and has medical process/program management/ownership. This includes project leadership, employee coaching, mentorship, and supervision of support and entry-level professional associates.
- Preferred: Ability to apply expertise to improve effectiveness and provide clinical and technical guidance to employees on the team.
- Highly preferred: Knowledge of and experience using and interpreting basic biomedical statistical methods.
- Required: Conduct literature searches/reviews, design studies per scientific methods, and complete basic statistical analyses on results.
- Highly preferred: Experience participating in and/or managing investigational drug or medical device studies, including conducting literature reviews, study design and execution, and compliance monitoring.
- Required: Experience in continuous process improvement projects and project management.
- Preferred: PMP certification
- Highly preferred: Prior clinical practice experience with BD product categories.
- Preferred: Prior experience with medical product development.
- Highly preferred: Demonstrated excellent verbal and written communication skills, including the ability to write scientific papers and present at professional conferences.
- Highly preferred: Work experience with multi-disciplinary/cross-functional teams.
- Highly preferred: Comfortable working in a position that requires flexibility within a fast paced, multi-task matrixed environment.
Any Additional Information
- Travel may range from 15-30%, overnight travel, including US and international.
- Position requires flexible working hours, including some nights and weekends, as needed for the support of customer and business activities.
Meet Your Recruiter Manikandan H
Job Tags
Full time, Contract work, Work experience placement, Local area, Flexible hours, Night shift,