Clinical Project Manager Associate

anager Associate (CPMA) will work in the Newark facility and participate in the preparation and execution of Phase I-IV clinical trials. This position supports the CPM and projecct team in the implementation and monitoring of clinical trials in accordance with Good Clinical Practices, regulatory requirements and procedures set forth by Biotrial and Sponsors. The CPMA will be responsible for effectively interfacing between the different departments within Biotrial (France and USA).

RESPONSIBILITIES OF THE CLINICAL PROJECT MANAGER ASSOCIATE include:

Coordination and Document Management:

· Communicate study-related items internally with CPMs and externally with Study Sponsors, Regulatory Authorities, IRBs, Investigative Centers and External Providers. Work collaboratively with co-workers.

· Assist with the coordination of team member tracking.

· Development of study binders (ISF and PSF (electronic or paper)).

· Regular update of the study folder on the server.

· Regular update of paper or electronic Trial Master File (TMF).

· Assist with TMF oversight including routine quality checks and to maintain a complete and inspection readiness.

· Supply of study documents/material to study sites, from initiation to close out (paper ICFs, Amended documents, etc.).

· Assist with organization of investigative meetings, implementation meetings and other meetings related to the studies (internally and externally) as may be required including meeting scheduling, invitations, meeting materials; Reservations / preparation of rooms, and meals; travel arrangements of the investigators' trips in collaboration with reception, including (train, hotel, air travel, etc.).

· Participation in Telephone Conferences and minute writing.

· Manage study documentation archival per internal processes, at the end of each clinical trial.

· Assist CPMs with daily operational activities as needed.

Document Drafting:

· Assist with the CPM for the IRB submission (initial submission, amendments, case reporting, etc.)

· Coordinate document translation, if required.

· Drafting letters and administrative documents relating to the study.

Regulatory:

· Assist project teams with study specific documentation and guidelines as appropriate.

· Assist with the study documents creation including ICF, protocol amendments, file notes, clinical data summaries.

· Participation in the preparation of sponsor audits and / or regulatory inspections.

· Assist in quality assurance audits of clinical study documentation (e.g., Main Study Files, CRF Files, Monitoring Files, etc.).

· Other duties as assigned.

EDUCATION AND EXPERIENCE requirements:

· Bachelor’s Degree in scientific area or related field of study.

· 2 years’ experience in clinical research or healthcare would be an advantage.

· Experience with a Trial Master File software would be an advantage.

OTHER SKILLS AND ABILITIES needed:

· You enjoy working as part of a team (team spirit is a plus), have strong organizational skills and can manage several projects at the same time (ability to multitask, prioritize, and manage time efficiently) in a procedural environment that requires meeting strict timelines.

· Proficient computer skills in Microsoft Office Suite.

· Excellent written and verbal communication skills, as well as interpersonal skills.

· Ability to work independently, efficiently, and accurately with high productivity. Being proactive is required.

· Detail-oriented and possess good trouble-shooting skills with the ability to prioritize and execute tasks in a high-pressure environment.

· Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.

· Ability to interact and collaborate with all levels of management, different departments within Biotrial (France and USA) and sponsors.

· Knowledgeable of clinical research process/environment helpful.

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

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

Application Question(s):
• Do you have experience with Veeva Vault?

Experience:
• Clinical research: 2 years (Preferred)

Work Location: In person