Lead Site Manager
We are looking for a driven Lead, Site Manager, Oncology / Haematology located Turkey, to serve as primary contact between the Sponsor and the Investigational Site. As Lead, Site Manager you will have outstanding capability to engage with key sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure.
Responsibilities may include assisting with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The Lead, Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols. You will lead process improvements at country, regional, and global levels as well as training and mentoring of other Site Managers. A Lead, Site Manager operates independently and performs clinical trial tasks proficiently, identifying opportunities for streamlining processes. Additionally, you will oversee, train and mentor more junior Site Managers when required and support leadership at a study level as requested.
Who is Johnson & Johnson Innovative Medicine? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring ground breaking science and the most creative minds in the industry together to think differently about diseases. We seek not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.
Are you ready to join our team? Then please read further!
Principal Responsibilities

• Serve as the primary contact for assigned trial sites.
• Provide insights during site feasibility and qualification visits.
• Lead investigator meetings and facilitate discussions.
• Oversee site initiation, start-up, monitoring, management, and close-out activities according to SOPs and policies.
• Implement risk-based monitoring and work with sites to resolve issues promptly.
• Train and mentor junior Site Managers; support with accompanied site visits as needed.
• Ensure site staff are trained, with accurate and complete training records.
• Collaborate with the LTM and central team to expedite site activation.
• Contribute to site-level recruitment strategies and contingency plans.
• Ensure site supplies and clinical drug handling are appropriate and compliant.
• Verify data accuracy and ensure timely reporting of adverse events and product complaints.
• Maintain timely, accurate data and documentation in trial management systems.
• Document trial activities, write visit reports, and communicate status and issues to stakeholders.
• Review study files for completeness and ensure proper archiving.
• Collaborate with the LTM to track site progress and resolve issues.
• Lead or participate in team meetings and trainings, offering leadership and feedback.
• Act as a local expert on assigned protocols, with in-depth therapeutic knowledge.
• Ensure Corrective Action Preventative Action (CAPA) for site audits is completed.
• Prepare trial sites for close-out and conduct final visits.
• Track site costs and payments; support LTM in country-level cost tracking if required.
• Build strong relationships with internal and external stakeholders, including investigators and site staff.
• May handle site communications or act as Site Engagement Lead.
• May assist with Health Authority (HA) and IRB submissions as needed.
• Serve as a site management expert, providing advice and sharing best practices.
• Act as a coach and mentor to less experienced Site Managers.
• Contribute to process improvement and training initiatives.
• Lead or participate in special projects and assume additional responsibilities, such as acting as a “Champion” or “Subject Matter Expert.”

Qualifications

Education and Experience 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 6 years of clinical trial monitoring experience is required. 8-10 years of clinical trial monitoring experienced is preferred; however, other relevant experiences and skills may be considered.

• Experience in mentoring/coaching and providing training to others SM. Strong leadership skills, ability to lead initiatives, to act as a lead SM.

• Oncology / Haematology therapeutic area experience, knowledge or expertise is expected and required. Significant years of experience in key therapeutic areas will be an added advantage.

• Expert knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.

• Strong IT skills in appropriate software and company systems.

• Willingness to travel with occasional/regular overnight stay away from home depending on the region.

• Proficient in speaking and writing the country language and English. Good written and oral communication skills.

• Flexible mindset and ability to work at a fast pace within small exploratory international study teams in a fast-changing environment. Demonstrated problem solving capability and ability to manage stressful situations.

Ability to work on multiple trials in parallel in different disease areas. 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:
We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our enthusiastic organization. We are Janssen!
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.