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.
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