About the role

  • Lead Site Manager executing site management and monitoring duties for clinical trials at Johnson & Johnson. Collaborating with international teams and mentoring junior staff in the process.

Responsibilities

  • Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies.
  • Responsible for the implementation of analytical risk-based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
  • Able to implement and execute all tasks independently with great proficiency.
  • Also expected to oversee, train, mentor more junior Site Manager and support functional manager with completion of junior site manager accompanied site visits (ASVs) as required.
  • Leads collaboration with LTM for documenting and communicating site/study progress and issues to trial central team, proposing solutions and strategies for improvement and leads additional country insight gathering.
  • Act as local expert in assigned protocols.
  • Possesses in-depth therapeutic knowledge sufficient to support role and responsibilities as well as other Site Managers within the same therapeutic area.
  • Acts as a point of contact in site management practices.
  • Able to provide authoritative insights, expert advice and share best practices
  • Will routinely be assigned as a coach and mentor to a less experienced site manager.
  • Expected to contribute to process improvement and training.

Requirements

  • A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences or related scientific field (or equivalent experience) is required.
  • A minimum of 4 years of clinical trial monitoring experience is required.
  • Experience in mentoring/coaching and providing training to others SM.
  • Strong leadership skills, ability to lead initiatives, to act as a lead SM.
  • Specific therapeutic area experience, knowledge or expertise is expected and required.
  • Flexible mindset and ability to work at a fast pace within small exploratory international study teams in a fast-changing environment.
  • Demonstrated capability to consistently deliver clinical trials of high complexity or high degree of difficulty.
  • Able to anticipate obstacles and proposed solutions to manage them effectively.
  • Demonstrated strong site engagement/site relationship capability especially with identified key/strategic sites.

Benefits

  • inclusive work environment
  • professional development opportunities

Job title

Lead Site Manager

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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