Job Details

Temp Clinical Trial Manager

The Opportunity:

This is a unique opportunity for a Clinical Trial Manager (CTM).  You will be responsible for independently managing one or more Phase 1-3 studies or complex components of larger trials with cross-functional oversight and vendor management.

Responsibilities:

• Apply advanced expertise and exercise considerable latitude to determine objectives and to develop effective solutions to guide the successful completion of complex assignments under limited supervision

• Participate in the Clinical Study Execution Team (CSET) discussion and may lead aspects of the meeting agenda as it pertains to vendors, study metrics, etc.

• Drive site activation and document readiness activities; analyze enrollment and operational metrics, supporting study lead in decision-making

• Participate and sometimes lead meetings internally and externally with CROs, vendors, and multi-functional teams with minimal supervision

• Lead TMF reconciliation and inspection readiness activities

• Support the review of study documents such as protocols, ICFs, CRFs, monitoring plans, etc.

• Lead department process improvement initiatives

• Participate in CROs/vendor trainings as it relates to a limited aspect of study requirements

• Manage the CRO and some ancillary vendors and ensure deliverables

• May participate in the interview process for similar or junior roles within Clinical Operations

• Mentor and support Clinical Trial Assistants (CTAs) and Clinical Trial Management Associates (CTMAs)

• Follow up and follow through on team action items and identification, escalation, and resolution of issues as needed.

• Review and identify trends when performing routine data surveillance of data listings, and support in the preparation of interim and final Clinical Study Reports and resolution of data discrepancies.

• Support other Clinical Operations activities as appropriate.

• Required Skills, Experience and Education:

• BS, BA, or RN in a relevant scientific discipline.

• 5-7+ years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.

• Advanced knowledge of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures.

• Strong communication and coordination skills; global trial experience and strong operational judgement.

• Proactive contributor to trial execution and issue resolution, with strong ownership of responsibilities for complex studies with multiple sites.

• High sense of priority and commitment to excellence in the successful execution of deliverables.

• Ability to analyze operational data, perform with an emphasis on quality, timeliness and multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.

• Travel may be required (~15%).

• Preferred Skills:

• Decision-making skills.

• Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).

• Oncology experience, early and/or late stage, strongly preferred.