The Clinical Operations Senior Project Manager (SPM) is responsible for overall management of all phases of clinical trials, from start-up through completion of activities, utilizing MedSource or sponsor Standard Operating Procedures (as applicable), FDA regulations, and ICH-GCP guidelines. In-depth knowledge and experience of the drug development process is required, including study initiation, clinical monitoring, drug safety, regulatory affairs, data management and analysis, and clinical study report generation.
The primary responsibility of the SPM is to provide day-to-day technical leadership and administrative supervision to a team of Project Managers (PM), Associate Project Managers (APM), and Clinical Research Associates (CRA) engaged in the execution of clinical research protocols. Participate in the development and implementation of operational strategies and policies and procedures for the Clinical Operations Department. The SPM will be accountable for multiple projects/sponsors. Ensure 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, 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.
- Assists the study leads in managing cross-functional teams to review clinical trial timelines, objectives, deliverables, quality issues and other day-to-day operations.
- Works closely with VP and Associate Director/Director of Clinical Operations to identify and manage 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.
- Communicates with study sites regarding issues that involve protocol deviations, patient participation, case report form completion, and other study related specifics.
- Performs field visits to assess monitor performance and other training visits as needed.
- Reviews phone contact reports, expense reports, timesheets, and monitoring trip reports.
- Provides annual evaluations for staff and hold mid year career progress and development meetings.
- Participates and presents at investigator meetings and client meetings.
MINIMUM JOB REQUIREMENTS:
- BA/BS in a Life Science.
- Minimum of 8 years of experience in clinical research and 4 years in a 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.
- 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.
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, ICH and 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.
We are committed to diversity in the workplace and are an equal opportunity employer.