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Boston Scientific · 17 hours ago

Clinical Trial Manager

Maple Grove, MN

Full-time

Hybrid

Mid, Senior Level

$99K/yr - $188K/yr

5+ years exp

Boston Scientific is a leader in medical science committed to solving health industry challenges. The Clinical Trial Manager will lead global clinical studies for the Renal Denervation portfolio, managing cross-functional teams and ensuring compliance with regulatory requirements.

Health CareMedicalMedical Device

No H1B

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

Qualification

Clinical trial experienceClinical Practices (GCP)FDA regulationsProject management toolsMedical device trialsCardiovascular therapeutic areasRisk managementRegulatory submissionsCross-functional collaboration

Required

Minimum 5 years related work experience with Bachelor's degree or 3 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)

Preferred

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

Benefits

Compensation may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).