The Clinical Project Manager is responsible for managing assigned clinical trials as well as providing leadership in the implementation of new process improvements across future and ongoing programs. The role requires active involvement to meet schedules or resolve problems or conflicts, and entails frequent interaction with clients, functional peer groups at various management levels and senior management. This position may have line management responsibilities for Clinical Trial Associates and will interface with clients to promote exceptional program oversight.
Schedule and review project tasks, providing leadership in the delivery of services to clients and ensuring staff fulfills their responsibilities in accordance with client’s policies, procedures, SOPs, ICH-GCPs, and country specific regulatory requirements.
Responsible for creating and maintaining timelines for each project, and use these timelines to track and manage a project’s progress to timely completion in compliance with all regulations and SOPs.
Writing study plans, including Study Management Plans and Communication Plans
Prepare project status reports, both internally for Ora and for the Sponsor.
Overall responsibility to deliver the projects on time and on budget.
Writing of study documents, including protocol, ICF, source documents and study logs.
Interface with data management and statistics group and coordinate these activities in concert with them.
Oversight of clinical sites, including site start-up (e.g. completion of regulatory documents and IRB approvals), subject recruitment, data entry/transcription, timely completion of logs (e.g. Screening/Enrollment and AE logs).
Interface with monitoring department and CRAs to coordinate monitoring activities in concert with them, as agreed upon in the study monitoring plan. Aide in follow-up with the sites to ensure timely completion of action items from monitoring visits.
Communicate status of study to Sponsor by ensuring study tracking logs are updated on a weekly basis. Participation in weekly update calls with Sponsor and data management/statistics group. Oversee and review writing of minutes, including action items, from team and Sponsor conference calls.
Comply with regulatory, GCP, ICH, and SOP guidelines.
Participate in client presentations and/or bid defense meetings, as required.
REQUIRED SKILLS AND ATTRIBUTES:
Understand, follow, and properly execute the roles and responsibilities as defined in the agreement with the Sponsor.
Ability to prepare a clinical trial outline, protocol, informed consent form, source document, and an investigator study summary.
Aptitude to coordinate clinical trial timelines and resources.
Ability to track and report clinical trial timelines and resources.
Strong interpersonal skills.
Proficient in the Microsoft Office Suite.
Excellent written and verbal communication skills.
Excellent organization and time management skills
Bachelor’s degree in applied or life science,
Minimum of 4 year’s experience in clinical trials, or equivalent training and work experience.
Knowledge and experience with Ophthalmology clinical trials is preferred.