Senior Clinical Project Study Manager - Hybrid, MUST BE onsite 2 days , Boston area, Massachusetts
Position pays around $160,000 to $175,000 base (depending on experience) plus 15% bonus , stock and full coverage on health benefits.
Summary:
We currently have an expanding client in the Pharma/Biotech industry working in the renal disease areas with advanced technology using a patient's own cells that could prevent or delay dialysis or transplant.
This is a late stage Pharma/Biotech company focused on the development and pioneering of cell therapy for the treatment of Renal Disease. The company is expanding and looking to add a Senior Clinical Project Study Manager who has strong clinical operations experience managing all aspects of studies that include overseeing CRO's/Vendor Management.
This position requires a solid understanding of clinical drug development, GCP and regulatory requirements for clinical trials process. Ability to multi-task and manage cross-functionally when making decisions.
Responsibilities:
Responsible for all aspects of clinical trial management aimed at treating moderate to severe renal disease.
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.
Develop study specific plan's including key milestones, objectives and timelines.
Manage CRO's 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.
Ensure country and site feasibility and selection.
Manage critical study documents, such as consent forms, study manuals, subject recruitment materials.
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).
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.
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.
Required:
BS degree in a scientific related area is required.
4-5 years of clinical operations experience working for a direct pharmaceutical/biotech company (Sponsor side only).
3-4 years experience as a Senior Clinical Study , Project or Trial Manager.
Must have Phase III-VI experience clinical trials.
Experience with global clinical trial operations, in multiple phases of research, including late stage.
Strong knowledge of ICH , GCP, FDA guidelines and regulations.
Strong clinical trial , site startup, vendor management and oversight experience.
Experience in rare disease, pediatric, diabetes, renal or kidney and/or complex clinical trials highly preferred.
**MUST have current/direct Pharma or Biotech experience