Clinical Project Manager (Remote) - United States
- Our company is the leading global provider of outsourced clinical research services.
- Customers include the leading global pharmaceutical companies as well as biotechnology and small to mid-sized pharmaceutical companies.
- Our focus is on the development of innovative pharmaceuticals with the goal of enabling companies to reach early decisions concerning which compounds to progress further into clinical development.
- Supporting our clinical work are two world class bio-analytical laboratories located in Europe and the U.S.
- Our company is unique from other leading CROs in that our focus is on early phase clinical studies through clinical proof-of-concept, and beyond.
- Early Clinical Research and studies required to support product labeling
- Data Management and Biometrics (modeling and simulation, study design and protocol development, clinical data management, biostatistics, PK/PD, medical writing and reporting)
- Bioanalytical Services (discovery to late stage services with capabilities in small and large drug, metabolite and biomarker molecules)
- Drug Development Services (Regulatory affairs and drug development consultancy)
- Global Clinical Development including project management and monitoring
- Our company is looking for a Clinical Project Manager who will be responsible for the independent management of multi-center site activities ensuring compliance to protocol, ICH Good Clinical Practices, Standard Operating Procedures and regulatory and local requirements.
- This role will be home based anywhere in the United States. Due to our international footprint, schedule flexibility is important.
- This position will travel roughly 30% primarily in the US, but could include Europe on an as needed basis.
- Lead the initiation, maintenance and close out activities of multi-center studies in accordance with the protocol, GCP, and relevant SOPs
- Support the evaluation of suitability of site personnel and facility for initial and ongoing conduct of clinical trial
- Verify the accuracy and integrity of study data through collaboraton with data management
- Monitor screening and recruitment activities, assist site personnel with strategies to ensure enrollment is on target
- Participate in development of study plans such as monitoring, data management and safety plans
- Coordinate activities with central laboratories and other external service providers
- Update and review of clinical trial management tracking systems (CTMS)
- Review budgets and contracts
- Maintain appropriate and effective communication with sponsor and other internal departments to ensure successful project completion
Qualification and Skills Requirements:
- Bachelor's degree required, preferably in science, nursing, other biomedical discipline, or equivalent
- Seven to ten years clinical research experience as a CRA or equivalent, such as research coordinator with minimum of 3 years of direct clinical project management experience
- Experience in support of business development processes; including budgets, proposals and bid defense planning and execution
- Ability to work across multiple projects
- Flexible and willing to travel up to 30% (regional)
- Excellent problem-solving and decision making skills
- our company is an equal opportunity employer.