The Clinical Operations Senior Project Manager (SPM) is responsible for the overall management of all phases of clinical trials utilizing MedSource or sponsor Standard Operating Procedures (SOPs) as applicable, FDA regulations, and ICH-GCP guidelines. The Senior PM possesses in-depth knowledge of and experience in the drug development process, including study start-up, initiation, clinical monitoring, drug safety, regulatory affairs, data management and analysis, and clinical study report generation.
The Sr. PM is responsible for day-to-day oversight of all functional area operational activity and impacts to study development, implementation, and maintenance for successful study execution. The SPM will be accountable for multiple projects/sponsors. Accountable for project deliverables meet sponsor’s time, quality, and cost expectations. Work with third party vendors to evaluate study progress, issues, make sound decisions to ensure resolution is achieved. SPM will be accountable for managing project budgets and providing accurate resource allocation forecasting. Manages client relationships and expectations successfully.
DUTIES AND RESPONSIBILITIES:
- Manages all operational, financial and contractual aspects of assigned study(ies), recognizes milestones for timely invoicing and develops contract modifications as needed.
- Mentors PMs, APMs, CTLs, and CRAs especially in the areas of effective time management, communication, utilization of project management processes and tools.
- Provides leadership and motivation to departmental personnel.
- Participates in the development and execution of operating goals and objectives for clinical operations; recommends and implements procedures to enhance operations.
- Leads cross-functional teams to review clinical trial timelines, objectives, deliverables, quality issues and other day-to-day operations.
- Leads conference call meetings with the internal study team(s).
- Leads weekly sponsor team meetings to discuss the overall study status and high-level timelines and deliverables.
- Works closely with PD, VP and Associate Director/Director of Clinical Operations to identify, manage, and present solutions with areas of potential resourcing conflicts given simultaneous management of multiple programs.
- Participates in staff hiring, training, and coordination of work assignments, and evaluates performance of staff.
- Participates in proposal development and bid defense meetings as assigned.
- Develops quality standards and programs; monitors and maintains quality of study performance in accordance with internal policies and standards and contract parameters (i.e., visit report and follow-up correspondence review).
- Designs, communicates, and implements project plans including project tracking and timeline management tools.
- Facilitates the development of budgets and contracts with the sites and with outside vendors.
- Develops training for the clinical project team for therapeutic area and for any study related processes.
- Plans/Manages Study Kick Off meetings, Project Review Meetings, and study close out meetings.
- Oversees and Communicates with study sites regarding issues that involve protocol deviations, patient participation, case report form completion, and other study related specifics to seek document resolution.
- Reviews and approves phone contact reports, expense reports, timesheets, and monitoring trip reports.
- Leads presents at investigator meetings and client meetings.
- Oversees the implementation, maintenance of the eTMF and transfer to the sponsor at study conclusion.
MINIMUM JOB REQUIREMENTS / QUALIFICATIONS:
- BA or BS degree
- Minimum of 8 years of experience in clinical research and 4 years in a full-service project management role within a CRO and/or Biopharmaceutical is required. Prior site monitoring experience preferred.
- Personnel management experience, including performance review, time management and prioritization, resource allocation, etc.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
- Excellent oral and written communication skills.
- Good customer/client relationship management and proactive problem-solving skills.
- Knowledge of the principles, methods, and procedures of basic medical and/or clinical research.
- Knowledge of scientific experimental design and methodology and protocol development.
- Knowledge of FDA, global regulatory requirements and ICH-GCP guidelines for the conduct of clinical trials in human subjects.
- Ability to manage, review, and evaluate financial aspects of the project/sponsor and MedSource.
- Ability to motivate and provide technical leadership, advice, guidance, and direction to all levels of staff.
- Staff development and performance management skills.
- Ability to analyze and interpret data and prepare evaluative summary reports.
- Ability to develop and deliver presentations.
- Ability to develop and implement clinical research study plans and standard operating procedures.
- Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment (both verbal and written).
- Ability to handle multiple tasks simultaneously, meet rigorous timelines, and work effectively in stressful situations; proven initiative in managing in all aspects of a study.
- Adapts easily to change and endorses/encourages staff adoption of change.
- Excellent interpersonal and organizational skills with strong attention to detail.
CONDITIONS OF EMPLOYMENT:
Verification of educational requirements, employment history, professional references, and certifications/training.
WORKING CONDITIONS AND PHYSICAL EFFORT:
- Ability to travel approximately 20% both domestically and internationally.
- Must possess a valid driver’s license, passport, and maintain a personal credit card or have an available line of credit for charging travel expenses.
MedSource is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.