Practice Group Manager overseeing support and operations in mental healthcare offices across Georgia. Ensuring clinical and financial objectives are met while cultivating team performance.
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
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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