Clinical Research Project Manager (2+ years Clinical Trials Exp. Required)

Biotrial

Newark

CDI

Résumé de l'offre

• 90000 - 120000 USD / an
• BEP/CAP
• Employé/Opérateur/Ouvrier Spe/Bac
• Qualité/Hygiène/Sécurité/Environnement
• Industrie Pharmaceutique/Biotechn./Chimie
• Santé/Social/Association
• Exp. 1 à 7 ans

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.

Bienvenue chez Biotrial

Biotrial is a leading CRO specializing in Drug Development with a wide range of expertise in preclinical pharmacology, clinical development, bioanalysis, biometrics and ECG, CNS and Imaging Core Lab. With over 35 years of experience in providing scientific and medical services in clinical development, Biotrial offers innovative, tailor-made solutions to Biotech and Pharmaceutical companies.

Infos complémentaires

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Clinical Research Project Manager (2+ years Clinical Trials Exp. Required)

• Newark
• CDI