Sr Clinical Study Manager

3 weeks ago

Boston, United States CareerBuilder Full time

ProKidney is a late clinical-stage biotech company focused on the development of a pioneering cell therapy candidate that aims to transform the treatment landscape for Chronic Kidney Disease, with the potential to preserve kidney function and change patients' lives. We are currently growing and looking to add an experienced Sr. Clinical Project Manager who has at least 3+ years of current clinical operations experience with a Pharmaceutical company (NOT a CRO), managing all aspects of studies not just overseeing our CRO partners (Vendor Management experience highly desired). This is an Hybrid position Based out of our BOSTON, MA office. This position requires a solid understanding of clinical drug development, GCP and familiarity with regulatory requirements for the conduct of clinical trials. Strong attention to detail. Excellent written and oral communication skills. Able to effectively use information technology with a proficiency in MS Outlook, Word, Excel and PowerPoint. Exceptional planning and organizational skills. Ability to multi-task and manage cross-functionally and use good judgment when making decisions.
Responsibilities:
We are looking to hire a Sr. Study Manager, Clinical Operations(CSM). This is a unique opportunity to work in a growing Clinical Operations Department that manages late stage clinical programs based on an innovative Regenerative Medicine Advanced Therapy (RMAT) technology platform. The CSM will be responsible for all aspects of clinical trial management aimed at treating moderate to severe diabetic kidney disease. You will be responsible for the successful execution of clinical trials from protocol finalization through closeout.
* Collaborate with the Clinical Program Lead and study team to develop patient recruitment strategies, operational feasibility and implementation of study initiatives
* Management of the CRO's contracted scope and services (regulatory, site management, etc.) to ensure quality, timely performance and accountability for agreed responsibilities, timelines, quality and budgets.
* Regularly communicate trial status, issues, and mitigations to relevant cross-functional stakeholders. Proactively identify project risks and resolution
* Develop study specific plan(s) including key milestones, objectives and timelines
* Ensure country and site feasibility and selection
* Participate in the development and testing of clinical systems (e.g., data capture, IxRS)
* Ensure internal and external systems are updated in a timely manner (e.g., internal and study trackers, clinicaltrials.gov)
* Manage critical study documents, such as consent forms, study manuals, subject recruitment materials
* Oversee the Trial Master File (TMF) and assist with the periodic audits of the TMF
* Drive critical clinical trial activities including site activations, recruitment, and database lock
* Assist in contract and budget negotiations with clinical sites and vendors as well as budget review and forecasting
* Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science, QA team members etc., both internally and externally including our CRO Partners, to ensure ongoing performance alignment
* Participate in the development of tools and the reporting of metrics for monitoring clinical study progress and surveillance of key efficacy and safety data points.
* Collaborate with other functions (at CRO or internally) to ensure robust plans for study level data review, including trend evaluation
* Provide input in internal/external study related audits, review resulting reports and ensure appropriate mitigations and follow up
* Help review monitoring reports and, if applicable, drive corrective action site plans and provide oversight to ensure safety concerns etc. are identified and responses implemented
* Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards
* Train study team members, external monitors, and site staff as needed
Qualifications:
* Bachelor's degree in a scientific discipline is required
* 5+ years of clinical operations experience working for a pharmaceutical company (not a CRO)
* 3+ years of experience as a Senior Clinical Study/Trial Manager
* Located in the Boston Area
* Phase III-VI experience preferred
* Experience with global clinical trial operations, in multiple phases of research, including late stage
* Strong knowledge of ICH guidelines, GCP and FDA regulations
* Experience with all aspects of trial and site startup and vendor management and oversight
* Experience in rare disease, pediatric, and/or complex clinical trials preferred
* Ability to deal with multiple priorities with aggressive timelines
* Very strong oral and written communication skills
* Ability to find creative solutions to issues impacting timelines and budgets

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