14695 Safety Trial Manager - Marlborough

Job Description: Are you an innovator looking for a new challenge? Join Boston Scientific! We are growing - and looking to add a Safety Trial Manager to our Global Safety Office. This position is in our newest facility in Marlborough, MA - conveniently located off of Rte 495, Rte 85, and the Mass Turnpike.

Safety Trial Manager
General Summary:
Provides regional and/or global leadership for the management of the safety monitoring process for particular clinical trials. Assists project team in the design and execution of high quality clinical studies to ensure safety and effectiveness of BSC products. Works under the direction of management on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Interfaces with other departments, senior Clinical management, medical directors, senior functional management, and acts as BSC representative with CRO's.



Duties and Responsibilities:

Responsible for the management of dynamic safety processes by tracking adverse events, monitoring timelines for event processing, reviewing safety data at regular intervals, and monitoring adjudication results by the Clinical Events Committee (CEC).

Assists in the management of the adjudication process and interacts with core labs

Assists in the development and management of safety trial budgets and resource planning.

Contributes to CRF and protocol design as well as database validation.

Works closely with Safety Trial Operations management to facilitate accurate and timely adverse event processing and reporting and with the Medical Research Associates (MRA) as they compose the narratives for individual adverse events.

Interfaces with project team members and investigators to ensure a timely and precise safety reporting process for the therapeutic program which they support.

May be accountable for one or more concurrent clinical studies.

May train and mentor Safety Trial Operations staff on safety processes.

Participates in and assists in the development and approval of global safety strategies in collaboration with Clinical Sciences management.

Reviews protocols for projects before submission for approval.

Reviews instructions for use for investigational devices.

Attends investigator and coordinator meetings representing the Safety group.

Provides oversight of safety concerns and/or adverse events to ensure they are identified and appropriate responses to such concerns are developed and executed.

Provides advice on the reportability of adverse events and other clinical trial issues to regulatory agencies.

Manages data release and review meetings for clinical projects; reviews and participates in finalizing and obtaining approval of final manuscript or final reports for projects.

Participates in the dissemination of safety information to the clinical team members and extended core team members, as appropriate.

Provides clinical support in working with Food and Drug Administration, including 510(k) and Pre-Market Approval (PMA) submissions, responses to FDA questions, and preparation at FDA advisory panel.

Assists in developing and maintaining Safety Trial Operations infrastructure such as the drafting and/or reviewing of SOPs, Guidelines and Work Instructions.

Assists in the development and review of corrective action plans as requested on internal/external audits and implements plans as required

Demonstrates working knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable BSC SOPs and policies.


Minimum Education & Experience:
Bachelor's-level degree required. Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred. 5+ years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials plus 1-3 years experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting. Previous experience with complex, global trials preferred


Working Conditions:
General office environment, with the potential for up to approximately 30% travel to research laboratory or hospital settings, meetings and other BSC facilities. Potential exposure to blood borne pathogens and other potentially infectious material

Searchable Keywords: 14695 Safety Trial Manager - Marlborough / gj-mo

Minimum Education Required: Bachelor

Years of Experience Required: At Least 3 Years

Expected Travel Time: About 25%

This company may offer relocation assistance.


Boston Scientific offers incredible opportunities to grow and advance, a dynamic work environment and an excellent benefits package. Boston Scientific is an equal opportunity employer, M/F/D/V.