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Clinical Trial Manager EP Job

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Date: Dec 4, 2018

Location: Diegem, BRU, BE

Company: Boston Scientific

About this role:

Responsible for driving the strategy and managing the execution of global clinical studies and clinical programs worldwide through clinical project managers and/or involving departmental or cross-functional teams in support of the organizations business objectives for product development and/or commercialization.

 

Your responsibilities will include:

  • Writes study protocols, protocol amendments, informed consents, clinical study project timelines and scientific papers for publication by evaluating scientific literature and publications, analyzing scientific data and staying abreast of current clinical practice.
  • Efforts and leadership supports product approval, indication expansion and claim support, and mandated post market requirements.

• Leads and drives the project team in the planning, execution and management of all operational aspects of clinical trials.

• Leads, directs and executes clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.

• Tracks development of and collaborates with the project team on all internal and external project materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions.

• Ensures the project team maintains a continuous state of audit readiness.

• In collaboration with the project team, leads the proactive identification, assessment, and management of clinical study risks.

• Informs and presents study progress and known risks to Clinical leadership.

  • Provides input into presentations needed for worldwide regulatory agencies, investigator meetings, Data Monitoring Committees, Advisory Boards and Interacts with Key Opinion Leaders and investigators involved in clinical trials
  • Responsibilities may include clinical risk management activities including input into DFUs and authorship of Clinical Evaluation documents (CES, CRBA, CDSR) for identification of harms and support of safety performance for product approval.
  • Mentors and coaches some level of Project Management.

 

What we’re looking for in you:

Minimum Qualifications:

  1. Bachelor’s degree and 4+ years of related work experience or an equivalent combination of education and work experience
  2. Clinical trial experience required
  3. About 30% traveling may be expected depending on projects

    Preferred Qualifications:

  1. Electro-physiology lab and catheter ablation knowledge (technical experience in the field would be a plus)
  2. Strong communication skills
  3. Strong team player, collaborative, ability to build relationships and work cross-functionally

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