Clinical Trials Project Director ( Commercial Pharmaceutical emphasis)
Our client is a well-established, growing Clinical Research Organization (CRO) seeking a Clinical Trial Project Director who may be located in their Frederick or Rockville, Maryland office, but will also consider a remote candidate for this position.. Our client has been named a top workplace by the Washington Post and offers exceptional career opportunities. If you are currently a Manager in a Pharmaceutical company and aspire to be at the Director level, this position may be ideal for you!
Their studies impact public health initiatives and commercial pharmaceutical research on a global scale occurring in more than sixty countries spanning across six continents. They are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. The organization offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.
Clinical Trials Project Director: Primary Purpose
The Clinical Trials Project Director will be responsible for managing multiple commercially-funded multi-center clinical trials through a well-trained team of clinical research and trial associates. The Director must possess strong leadership, skill in managing personnel and projects, a strategic mindset, excellent communication and presentation skills, and a clear focus on delivery and client satisfaction to succeed in this role. Prior experience and a track record of success in leading and executing commercially-funded research studies is required. Experience with transplantation or cellular therapy trials is preferred.
Clinical Trials Project Director Responsibilities
- Ensure that overall project deliverables, budgets, schedules, and performance standards are realistically set and attained, and that the project effectively fulfills all requirements.
- Track project deliverables using appropriate tools
- Develop and adhere to a timetable for production and delivery of contractually required reports and products
- Manage project scope and resources (i.e., budget, personnel, and subcontracts) to ensure that project tasks are performed efficiently and on a timely basis
- Proactively utilize both quality control and risk management activities to ensure project deliverables are met according to regulatory, client and company requirements
- Track and manage requests for out-of-scope activities; manage client expectations
- Monitor and report on study status and progress towards deliverables, and escalate issues if needed, to the sponsor and/or company executive management as appropriate
- Overall efficient day-to-day management of the study including proactively managing study level operational aspects of the internal study team including management of study timeline, budget, resources and vendors
- Serve as the primary point of contact for Clinical Operations aspects of designated projects and responsible for developing successful working relationships with clients and stakeholders
- Responsible for risk mitigation strategies, associated action plan and issue resolution
- Responsible for managing the project team, including ensuring all necessary project training is provided to assigned staff
- Collaborate with Business Development, Contracts Department, and management staff to negotiate and ensure timely execution of change orders
- Recognize the importance of, and create a culture of high quality deliverables and process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs
Clinical Trials Project Director Experience:
- Masters degree in a scientific discipline and 8 years of demonstrated working knowledge of scientific principles appropriate to the position, including at least 2 or more years serving as a clinical research specialist or in an equivalent position
- Bachelors degree in a scientific discipline and 10 or more years of experience plus 2 or more years serving as a clinical research specialist considered in lieu of Masters degree
- Prior CRO and/ or pharmaceutical industry management of clinical trials, preferably transplant, cellular therapy, ophthalmology or hematology/oncology trials
- Highly experienced project manager with successful track record of delivering complex/ high priority clinical trials within agreed time, quality and cost
- Knowledge of project management processes and tools. Qualification in Project Management (PMI certification) or equivalent is desirable
- Experienced in developing, implementing and managing budgets
- Excellent verbal and written communication skills, planning, decision-making, negotiation, conflict management and time management skills
- Demonstrated experience of establishing strong client relationships and relationships with management staff
- Experience in supervising staff and leading teams
- Ability to build and maintain positive relationships with management, peers, and subordinates
- Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials
- Fluent in written and spoken English
- Skilled in MS Office (Word, Excel, and PowerPoint) and MS Project