At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

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Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Support

Job Category:

Professional

All Job Posting Locations:

Ankara, Istanbul, Turkey, İzmir

Job Description:

Johnson & Johnson Innovative Medicine is recruiting for a Lead Site Manager to be based in Istanbul, Izmir or Ankara / Türkiye.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Essential Job Duties and 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.
• Will routinely be expected to assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”.

Qualification

• 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. Significant years of experience in key therapeutic areas will be an added advantage.
• 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.

Key competencies

• Strong communication skills
• Coaching mentoring
• Negotiation skills
• Relationship Building
• Strategic thinking skills
• Problem solving skills

 

 

Required Skills:

 

 

Preferred Skills:

Clinical Data Management, Clinical Evaluations, Clinical Research and Regulations, Clinical Trial Protocols, Clinical Trials Operations, Communication, Data Savvy, Empowering People, Issue Escalation, Laboratory Operations, Problem Solving, Program Management, Project Support, Research and Development, Standard Operating Procedure (SOP), Study Management, Technical Credibility