Clinical Project Manager

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Job description

*Overview*

A biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity. Working with our client means that you are part of a team that's passionate about transforming the lives of people living with rare genetic disorders of obesity. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

Our client seeks an experienced and highly motivated individuals to join its team remotely. Within the clinical development group, there are multiple ongoing and planned studies of Setmelanotide in rare genetic disorders of obesity. The positions will be responsible for independently overseeing all components of study execution and as such will routinely interact with the medical, translational research, regulatory, biostats and diagnostic groups to ensure deliverables are met.

*Responsibilities*

* Lead and manage integrations of all clinical study activities leveraging internal and CRO resources, expertise and knowledge
* Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies.
* Communicate and interact with Key Opinion Leaders.
* Lead vendor selection activities (RFP, proposals, meetings, selection, and all associated documentation).
* Manages vendor contracts and payments.
* Author of Clinical Trial Oversight Plan and oversee vendor/CRO performance, and their operational management activities, with the ability to leverage resources, expertise, and knowledge within the vendor.
* Participate in Case Report Form design, user acceptance testing in partnership with data management.
* Manage and provide input to development of master and country specific Informed Consent Form templates.
* Lead the development of contingency/risk management plans.
* Review key study metrics (e.g., recruitment, data processing, monitoring) to assess study progress and associated mitigation strategies as needed.
* Prepare budgets, timelines, and forecasts for clinical studies.
* Review all operational study plans (project plan, clinical monitoring plan, communications plan, TMF plan, IMP management plan) for clinical studies.
* Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance and Medical
* Affairs to execute study activities.
* Provide a variance analysis of budget to actual and notifies finance of projected cost over/under expenditure.

*Qualifications*

* Bachelor's Degree is required. An advance degree in scientific discipline, business/finance courses is preferred.
* 6+ years of experience gained with a CRO or Pharmaceutical Company working on Phase I - IV multinational clinical studies.
* Strong regulatory knowledge, including Good Clinical Practices (GCPs).
* Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problemsolving ability.
* Excellent communication skills (written and verbal).
* Knowledge of global clinical trial management in fast paced CRO outsourced environment.
* Ability to assemble a plan and execute on the details.
* Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
* Able to travel (annual average of 10 - 20%)