Clinical Project Leader
- Bridgewater, NJ
- Remote, US
- Full Time
The primary role of the Clinical Project Leader (CPL) is to act as the key operational interface with internal and external services to develop, implement, maintain and improve operational processes for clinical trial conduct. This position supports the CSU Clinical Investigators, medical advisor (MA), in the conduct and management of clinical trials. Oversees in-house Clinical Project Assistants (CPA’s), and oversees activities of CRA’s for clinical trials with awareness of related functions and roles. Significant operational planning and analysis is required.
Major Duties and Responsibilities:
- Responsible for the overall adequacy of conduct, data quality, compliance and adherence to timelines for their assigned trial(s)
- Interface with corporate CTOMs, CRA Team, MAs and CSDs for operational input for feasibility, trial design/methodology, standard medical practice and data capture
- Develop and manage the trial budget. Overall responsibility for negotiation of financial aspects of clinical trial.
- Collaborate with medical function in the safety evaluation of study subjects in ongoing trials.
- Ensure all aspects of study site management i.e. recruitment of qualified investigators, site initiations, conduct investigator meetings)
- Ensure enrollment criteria are met and other aspects of the study management as appropriate.
- Responsible for mentoring and team cohesion. CPL mentoring as needed
- Facilitate development of study tools and appropriate tracking systems for coordination of trials, grants, enrollment status and clinical supplies.
- Ensures adherence to contractual obligations of local vendor relative to the service provided, as appropriate.
- Contribute to operational details in specifications for local vendor contracts, as needed.
- Fulfillment of project timelines and patient accrual goals is primary goal/challenge.
- Motivating team effectiveness and communicating with Regional Teams and Management Teams is also high priority goal. [Partnering, mentoring, overseeing, responding proactively will aid in problem solving]
- Bachelor’s degree and 6+ years of clinical research experience; 1-2 years of field monitoring experience; prior demonstration of an ability to manage people and projects.
- Working knowledge of clinical study development, FDA regulations and ICH/GCP guidelines. Operational planning experience.
- Excellent interpersonal and communication skills (verbal and written), including proficiency in medical terminology.
- Professional demeanor with ability to interact effectively with scientists and managers from multiple disciplines; serves to provide internal operational expertise on assigned area and liaise with external organizations specific to clinical trial.
- Strong organizational and time management skills.
- Self-motivation and attention to detail.
- Proficient with computer systems, or willingness to learn.