Senior Clinical Trial Manager

Boston Scientific•Maple Grove, MN

46d•$127,900 - $243,000•Hybrid

About The Position

The Senior Clinical Trial Manager will lead the design, planning, execution, and oversight of global clinical studies for the Renal Denervation portfolio. This individual will manage cross-functional clinical teams to support business objectives related to both product development and commercialization. The incumbent will bring deep expertise in clinical trial operations, a strong understanding of regulatory requirements, and technical knowledge specific to the relevant therapeutic area.

Requirements

Minimum 8 years related work experience with Bachelor's degree or 6 years with Master's degree
Proven Clinical trial experience required (Sponsor or CRO)
Advanced knowledge of Good Clinical Practices (GCP), ISO 14155 and FDA regulations governing the conduct of clinical trials
Prior or current experience working with external vendors and Contract Research Organizations (CRO)

Nice To Haves

Current or previous experience with medical device clinical trials
Current or previous experience with cardiovascular therapeutic areas
Proven ability to use in-depth knowledge of business unit functions and cross-functional group dependencies/relationships

Responsibilities

Leads the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction. Provides project leadership and scientific expertise throughout the development and implementation of local or global clinical studies.
Writes study protocols, protocol amendments, informed consents, project plans and timelines; stays abreast of current clinical practice by analyzing scientific data from literature and publications.
Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines.
Tracks development of and collaborates with the study team on all internal and external project materials, processes, manuals, plans, committees, vendors, study systems and all sponsor required regulatory submissions.
Ensures the study team maintains a continuous state of audit readiness.
In collaboration with the study team, leads the proactive identification, assessment, and management of clinical study risks and emerging trends.
Facilitates communication between Sales & Marketing, Medical Affairs, Regulatory Affairs, R&D, Senior Management, Key Opinion Leaders/investigators and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior management.
Interacts with regulatory agencies as needed and will use their scientific knowledge to provide directives to staff as well as study sites.
Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
Presents scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings, investigational meetings and regulatory agency meetings.
Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional Review Boards, Ethics Committees, etc.