Clinical Research Project Manager 2+ Years Clinical Trials Exp. Required H/F Biotrial
- États-Unis
- CDI
- BEP, CAP
- Bac
- Service public hospitalier
- Exp. 2 ans
À noter sur ce job
Ce poste comporte des spécificités à connaître avant de postuler.
- Occasional travel may be required
Les missions du poste
- Manage and coordinate the activities of clinical trials with the Biotrial Project Team (CRA, clinical team, Data Managers, Statisticians, Medical Writers, etc.).
- Serve as the main point of contact and communicate with sponsors regarding project timelines, updates, needs and emerging issues.
- Develop study timelines based on protocols.
- Ensure project start-up activities by facilitating processes for preparation of regulatory documents, ensuring timely IRB/IEC approvals for clinical trials.
- Lead the internal project meetings including Kick-off meetings and Study Initiation meetings, etc. with sponsors/internal teams.
- Follow screening and recruitment activities to ensure timely enrollment in the trials.
- Organize and coordinate Safety Review Meetings with Investigator / sub-investigator / Medical and scientific affair members.
- Monitor and ensure that project scope and deliverables are fulfilled within timelines and budget.
- Support and coordinate with the Medical Writing team to ensure completion of the Clinical Study Report, as applicable.
- Review and manage study contracts/budgets. Collaborate with Billing and Accounts Department to ensure billing agrees with pre-established milestones.
- Review and approve Vendor/Site contracts, budgets and invoices.
- Regularly and in a timely fashion, interact with management, sponsors, and/or functional team members on matters concerning resource allocation, project milestones, regulatory issues, and other relevant issues.
- Organize sponsors' visit of the Clinical Pharmacology Unit (Site qualification visits, Initiation Meetings, Monitoring visits and Close-out visits).
- Occasional travel may be required for bid defense, initiation or kick-off meetings, or other study-related activities.
Le profil recherché
- Requires a B.S. degree in life sciences or related field.
- Minimum 2 years in managing projects in a Contract Research Organization (CRO) or industry. Experience in monitoring clinical studies is a plus.
- Good understanding of the drug development process.
- Excellent written and verbal communication skills, as well as interpersonal skills.
- Ability to interact with all levels of management, sponsor and study site personnel.
- Detail-oriented and possess good troubleshooting skills with the ability to prioritize and execute tasks in a high-pressure environment.
- Possess good trouble-shooting skills with the ability to prioritize and execute tasks in a high-pressure environment.
- Proficient computer skills in Microsoft Office Suite.
Infos complémentaires
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Les étapes de recrutement
Les étapes de recrutement peuvent varier selon l'offre à laquelle vous postulez.
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Premier contact téléphonique par notre service RH.
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Entretien avec vos futurs collègues et le service RH.
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Suivant le poste, vous pourrez réaliser une évaluation de personnalité professionnelle.
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Biotrial en images
Publiée le 30/09/2026 - Réf : 4366809/30414258 CRPMYCTER/N