Biotrial, a leading provider of high-quality pharmacology services, is currently recruiting a Clinical Project Manager for its U.S. headquarters in Newark, New Jersey.
The Clinical Project Manager is responsible for providing customer-focused leadership and project oversight. This position facilitates communication among team members, including study monitors, sponsor personnel, investigational sites, third party vendors and the Biotrial Project Team. The Clinical Project Manager oversees the successful implementation and monitoring of clinical studies to ensure that studies are conducted in accordance with ICH/GCP and applicable regulations. This position is based and will work in the Newark, New Jersey Clinical Pharmacology facility.
Duties and responsibilities relative to the management of Clinical Research studies will include:
- Manage and coordinate the activities of clinical trials performed in the Biotrial Clinical Pharmacology Units and/or in Hospital sites with the Biotrial Project Team and/or the third party vendors.
- Serve as the main point of contact and communicate with sponsors regarding project timelines, updates, needs and emerging issues.
- Organize and coordinate internal and external meetings including Kick-off meetings, Study Initiation meetings, Investigators Meetings and Safety Review Meetings with Investigator / sub-investigator / Medical and scientific affair members / sponsors / internal teams.
- Participate in the elaboration of the clinical trial(s) from the drafting of the contract to the finalization of the protocol
- Develop and maintain study timelines and clinical project plans including communication & project management plan, recruitment and retention strategy plan, monitoring plan etc.
- Set up the trial at the regional, national or international level (feasibility/selection of centres, management of experts, setting up of centre contracts, preparation of regulatory aspects, etc.)
- Establish and validate the specifications and schedule with the internal project team, the investigational centre(s) and the sponsor.
- Ensure project start-up activities by facilitating processes for preparation of regulatory documents, ensuring timely IRB approvals for clinical trials.
- Follow screening and recruitment activities to ensure timely enrolment in the studies.
- Monitor the progress of the study(s) at the national or international level in terms of timelines and quality by using the CTMS/eTMF tools.
- Coordinate the internal teams involved in the realization of the study(s) (support project manager, lead CRA, CRAs...) and external teams (service providers, sites, sponsors)
- Review and manage study contracts/budgets. Collaborate with Billing and Accounts Department to ensure billing is in agreement with pre-established milestones.
- Review and approve Vendor/Site contracts, budgets and invoices.
- Coordinate the activities of various support departments: medical management, regulatory affairs, pharmacovigilance, data management, biostatistics, pharmacokinetics, bioanalysis, medical writing etc.
- Occasional travel may be required for bid defence, initiation or kick-off meetings, or other study-related activities.
- Requires a Bachelor's degree (Masters a plus) in life sciences or related field.
- Minimum 3 years of experience in clinical trials management. Previous experience in CRO would be greatly appreciated.
- Knowledge of GCP and FDA regulatory requirements is required.
- Good understanding of the drug development process.
- Must have previous experience managing projects and in monitoring clinical studies.
- Excellent written and verbal communication skills, as well as interpersonal skills.
- Exceptional time management and conflict resolution skills required.
- Ability to interact with all levels of management, sponsor and study site personnel.
- Possess good trouble-shooting skills with the ability to prioritize and execute tasks in a high-pressure environment.
- CCRC certification preferred.
- Proficient computer skills in Microsoft Office Suite.
Biotrial is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, genetics, disability, age, veteran status, or any other characteristic protected by law.
Job Type: Full-time
- 401(k) Matching
- Dental Insurance
- Disability Insurance
- Employee Assistance Program
- Health Insurance
- Life Insurance
- Paid Time Off
- Vision Insurance
- clinical research: 3 years (Preferred)
- phase 1 clinical study: 3 years (Preferred)
- GCP and FDA: 3 years (Preferred)