Manager, Clinical Project Assistants
The Manager, Clinical Project Assistants is responsible for participating in the planning and hiring of clinical project assistant personnel. Directly responsible for the oversight, management and professional development of the clinical project assistant team. Responsible for the development, implementation of clinical project assistant systems and procedures and process review to ensure qualified and trained personnel perform timely and accurate support to the Clinical Team in accordance with company policies and procedures, Good Clinical Practice and all applicable global regulations.
- Plan, develop, implement and maintain processes/systems utilizing relevant Standard Operating Procedures (SOPs) to ensure global Clinical Project Management quality and efficiency.
- Maintain a positive, results oriented work environment, building relationships with management, colleagues and other departments communicating in an open, balanced and objective manner.
- Analyze and document clinical project assistant progress and issues. Implement corrective and preventative actions (CAPA) plans as needed. Develop solutions to enhance efficiencies
- Identify and implement Key Quality Indicators (KQI) and Key Process Indicators (KPI) to assure quality and effectiveness of service delivery to clients
- Coordinate and implement solutions based on results of KQI/KPI process analysis and feedback from clinical team
- Meets regularly with Operations Management team (and others as applicable) to proactively plan needs for upcoming studies, including identification of strategies to optimize staffing
- Ensure proper, adequate and appropriate Clinical Project Assistant (CPA) resourcing on clinical projects
- Supervise clinical project assistant team in accordance with Company and Sponsor policies, procedures and relevant SOPs, GCPs, ICH and ISO guidelines
- Assist staff to resolve complex or out of policy operation problems, escalating to management as needed.
- Track meeting agenda and meeting minutes’ timelines to ensure timely submission of meeting agendas and meeting minutes, subject visit follow-up emails, regular communication with Investigative sites; follow-up as necessary with Clinical Project Managers to confirm compliance with SOPs and applicable Plans.
- Provide feedback and training to team on various clinical project assistant activities (e.g. Informed Consent Review, Investigational Product Release Forms, etc.)
- Create and revise Standard Operating Procedures for Study Management tasks and processes as requested
- Conduct performance reviews and manage/coach employee professional development. Provide support to assist staff in meeting their personal developmental and positional goals
- Contribute to the proposal development process as appropriate (strategy development, content generation, costing, review)
- Develop a CPA Training Program to train CPAs at both the entry level as well as senior level
- Provide support to assist staff in meeting their personal developmental and positional goals
- Ensure and/or conduct at a minimum yearly on trial master file assessments ensuring quality and efficiency for each CPA
- Attend conferences and scientific meetings as needed for professional and business development
- Interface with clients and partner vendors during business development and contracting to establish project specifications and timelines
- Other duties as assigned
- A minimum of an associate degree from a two-year college is required. A bachelor’s degree from a four-year college/university in Business Administration, Life Sciences or another related field is desired.
- A minimum of three (3) years of clinical research experience in Project Management or Clinical Monitoring
- Prior experience at a pharmaceutical, CRO, or medical device company required
- Sound knowledge of Good Clinical Practice and FDA regulations/guidelines for clinical research, ICH and ISO 9001. Demonstrates attention to detail and organizational skills, possess solid time management skills, pro-active and displays a professional demeanor with a high focus on compliance and responsibilities. Ability to follow through and consistently demonstrate that all primary job duties and responsibilities are current and up to date. Ability to work effectively in an innovative and flexible environment. Strong interpersonal skills and ability to work as an effective team member and with cross-functional groups.
- Excellent English verbal and written communication skills. Ability to read and interpret documents such as regulations, SOPs, study protocols, medical terminology and equipment manuals. Ability to write routine reports and correspondence.
- Ability to handle multiple responsibilities and work well under pressure
- Self-starter, committed to finishing projects and completely while meeting project deadlines
- Experience in supervising, directing project and team activities
- Ability to read and interpret contracts as well as negotiations of the contract while including and clearing any changes with Supervisor
- Ability to work well independently and on a team and drive work through internal support departments
- Must be willing to travel (domestic and internationally) and work evenings and weekends as needed.