Expert Clinical Manager Job

Yoh has a contract opportunity for a EXPERT CLINICAL MANAGER to join our client in East Hanover, NJ.

JOB RESPONSIBILITIES:
- Responsible for all operational aspects of 1 or more OGD clinical trial(s) under the leadership of Clinical Trial Head (CTH). Support all scientific aspects of clinical trial(s) as assigned.
- Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards.
- Provide input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing.
- Prepare training materials and presentations related to the planning and conduct of the trial.
- Prepare clinical outsourcing specifications.
- Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget.
- Manage interactions with Oncology Development Operations and other relevant functions including Drug Supply Management and local medical organizations.
- Accountable for accuracy of trial information in all trial databases and tracking systems.
- Support the development, management and tracking of trial budget working closely with the appropriate partners in OGD.
- Participate in the organization and logistics of various oversight and Advisory boards; attend meetings. Point of contact for managing/answering questions related to trial procedures and patients' eligibility.
- Write CTT meeting minutes.
- May occasionally deputize for the CTH at Clinical Trial Team meetings.
- May participate in International Clinical Team meetings.
- Contribute to program level activities (eg, tracking of OGD program-related publications, development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions).
- Responsible for implementation of best practices and standards for trial management within the TA, including sharing lessons learned.

Job Qualifications:
- Involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in leading specific trial related activities like planning, executing, reporting and publishing activities.
- Excellent communication, organization and tracking skills.
- Strong operational skills and demonstrated ability to meet timelines.
- Proven networking skills and ability to train colleagues.
- Proven ability to work both independently or in a team setting, including a Matrix environment
- Knowledge of Good Clinical Practice; thorough knowledge of clinical trial design; understanding of the overall drug development process.
- Knowledge of principles for trial budgeting.
- Basic knowledge of oncology and/or hematology preferable
- Advanced degree or equivalent education/degree in life science/healthcare required accompanied with 2 years experience in clinical research or Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with 4 years experience in clinical

DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Kara Lloyd

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading HR Solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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