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Senior Clinical Study Manager

3 months ago

Boston, United States BiotechPharma Full time

Clinical / Senior Clinical Study Manager – Onsite, Boston MA

Hybrid, MUST BE ONSITE 2 days per week. No relocation for this role, MUST be local.


Expanding late stage biotech working in the Kidney disease areas looking to expand.

This position is focused on the development of a cell therapy to change the treatment for Kidney Disease. They are looking for candidates who have at least 4 years of clinical operations experience within a Pharmaceutical or Biotech environment, managing all aspects of studies and overseeing CRO partners (strong vendor Management experience highly desired). Must have Phase III experience. This position requires a solid understanding of clinical drug development, GCP and familiarity with regulatory requirements for the conduct of clinical trials.


Description:

Senior Clinical Study Manager, Clinical Operations 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 plans including key milestones, objectives and timelines and 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


Required:

Bachelor’s degree in a scientific discipline is required

4+ years clinical operations experience working for a pharmaceutical or biotech company (no CRO’s)

3+ years experience as a Senior Clinical Study Manager or Clinical Trial Manager is a MUST

Phase III-VI trials experience is a MUST

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

Very strong oral and written communication skills

Ability to find creative solutions to issues impacting timelines and budgets

***Position pays up to $170,000 base (depending on experience) plus 15% bonus & stock***