Job Details

Clinical Consultant – CPM 

Position Summary:
We are looking for an experienced clinical operations consultant to oversee our clinical trial. This is a hands-on position where the individual will coordinate, track, and manage daily activities and provide oversight for the CRO(s), ensuring speedy enrollment and full compliance with GCP and regulatory standards. This role is ideal for someone who is not afraid of rolling up their sleeves and building the systems necessary for successful clinical operations. The right candidate will communicate with clarity and urgency and be able to work collaboratively with the CRO to achieve the desired outcomes.
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Key Duties / Responsibilities / “What you’ll do”:

• Working closely with Clinical Development, perform day-to-day management and study oversight of full service CROs and third-party vendors to ensure successful clinical trial implementation and execution
• Ensure timelines/key deliverables (e.g. study recruitment, DBL) are on track and is accountable for assigned studies and on-time delivery of study milestones. Implement mitigations as required.
• Review and approve site budgets, ensure overall adherence to approved study budgets, collaborate with finance to provide input into financial reporting and financial projections.
• Manage and communicate study status updates to senior management including overall clinical operations plan for investigational trials including timelines, internal and external resources/costs, and critical deliverables.
• Provides oversight review of study documents including but not limited to study protocol, ICFs, study plans, site monitoring reports, Trial Master Files (TMF).
• Ensures study management team is actively and compliantly managing study efforts while adhering to best practices/SOPs.
• Proactively escalates issues to CRO and the internal team and resolves issues as necessary.

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Knowledge Requirements (Background/Skills/Experience):

• Bachelor’s degree or equivalent, in life science, or related field of study.
• 10+ years of clinical operations experience working in a major clinical CRO or pharmaceutical/biotech company, with a proven track record of hands-on experience running a trial from startup to close out.
• Have actively managed phase I and II clinical studies in multi-national setting and have served as a clinical operations lead for multiple studies.
• Demonstrated extensive experience and strong collaborative skills managing clinical CRO’s.
• Ability to work both independently and collaboratively with Clinical Development in a fast-paced, interdisciplinary team.
• Experience in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
• A strong sense of urgency, self-starter, and keen