Contract Senior CPM

Proclinical seeking an East Coast-based Remote Contract Senior CPM for a leading pharmaceutical company. The incumbent will be instrumental in supporting the clients clinical program on the development of a symptomatic treatment for pruritus in a variety of patients. The incumbent will have hands-on responsibility with the planning and management of late stage clinical phases of our pruritus program. Management of CRO relationships and internal company timelines is a key aspect of this position.

Must be eligible to work in the US.

Job Responsibilities:

• Responsible for the overall operational setup and execution of specific clinical studies related to our pruritus program from study concept through study completion, while adhering to scope and schedule requirements as per corporate goals
• Manage day-to-day activities associated with the conduct of multiple, concurrent clinical studies from initiation to study closure
• Alongside with clinical scientists, lead internal project or trial team meetings as applicable
• Manage study deliverables and timelines including, but not limited to: clinical monitoring, data management, statistics, medical writing, medical monitoring, clinical supplies, and safety to ensure proper conduct and timely completion of all phases of the project(s)
• Manage and assess protocol deviation documentation (in collaboration with Data Management team) and assess with team need for protocol amendment if applicable
• Participate in establishment of strategies for patient retention and recruitment as applicable
• Ensure adequacy of protocol from a clinical operation perspective and proper training of all study team members for adequate execution of such protocol
• Prepare team (CRO/internal) for interim analysis, as applicable
• Coordinate and present at investigator meetings and CRA workshops, as required
• Manage vendors (ie, selection, negotiation, implementation of work orders and change to work orders) and ensure execution of deliverables within approved clinical trial budget and timelines.
• Work with site liaison specialist and/or medical science liaison (MSL) team to facilitate the identification of prospective investigative sites and participate in final investigative site selection or liaise with vendors to ensure quality site selection.
• Ensure adequate site selection focusing on appropriate subject enrolment and CRA resource allocation
• Create and lead the development of study plans and study-specific working practices
• Provide support in the planning, design, and execution of required documentation in compliance with project plans, federal regulations, and ICH/GCP, such as monitoring plan, study management plan, recruitment materials and so on

Skills and Requirements:

• BA/BS/MS degree or equivalent education
• 10+ years experience working as a Clinical Trial/Project Manager
• 5+ years Lead CTM/CPM experience
• Global Phase III experience
• Dermatology experience is a plus

If you are having difficulty in applying or if you have any questions, please contact Ciara Noble at (+1) 323-518-2700 or c.noble@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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