The Clinical Operations Project Manager will serve as the project manager and collaborate with internal stakeholders (e.g clinical operations, data management, statistics, safety, commercial, and regulatory affairs) to ensure smooth, timely execution of clinical studies. Understanding of clinical trial operations, including budgeting, contracting, drug release and distribution, basic regulatory compliance, site monitoring and partnering with CROs is required. The Clinical Operations Project Manager has to be willing and able to adjust to multiple demands and shifting priorities. The chosen candidate has to have ability to meet day-to-day challenges with confidence and professionalism.
Candidates must reside in New Jersey.
Project manage various aspects of clinical development, including:
· Development of Protocol and Informed Consent Form documents in collaboration with cross-functional facilitation
· RFA/selection process to partner with a Clinical Research Organization, including budgeting
Monitor clinical project deliverables and timelines to ensure timely execution
· Coordinate development of site and CRA training materials, lab and pharmacy manuals.
· Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming and Chief Medical Officer
Attend trial project team meetings and issue minutes
Qualifications & Skills:
-PhD, MD, PharmD or MS in life sciences with some previous experience in clinical research or clinical development experience.
· At least 2-years of direct experience working with externally sourced CROs.
· Scientific expertise or ability to learn in the domain of assigned study/project. Basic knowledge of disease area, compound, current clinical landscape is required.
· Familiarity with clinical databases or and data capture tools (patient profiles, listings) would demonstrate the candidate’s familiarity with the scope of work.
· Proficient experience in medical writing such as authoring or co-authoring documents such as protocol, clinical study report, investigators brochure, patient narrative.
· Experience in performing review of clinical trial data in order to identify trends in safety or efficacy data.
· Project management skills
· Proficient with Microsoft Word/Excel/PowerPoint and Microsoft Project
· Ability to work cross-functionally is essential.
· Excellent communication skills, oral and written
· Ability to anticipate and timely escalate issues and to define appropriate action plans.
· Excellent decision-making and problem-solving capabilities.
What we offer:
· Strong team with dedicated and passionate employees
· · An excellent working culture
· Opportunities for personal development
· Entrepeneurial work environment
We offer a comprehensive package with competitive salary, paid holidays and sick leave, along with a medical benefits and 401(K) plan. In addition, we offer participation in our stock option compensation program.