Senior Site Manager

To support our team in Belgium & The Netherlands, we are currently hiring a Senior Site Manager.

Location Breda, The Netherlands & Beerse, Belgium

Position Summary:

A Senior Site Manager (SM) serves as the primary contact point between the Sponsor and the Investigational Site. A Senior SM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company SOPs, GCP, and applicable regulations and guidelines from study start-up to site closure. Responsibilities may include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The Senior SM will partner with the Local Trial Manager (LTM), Clinical Trial Assistant and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement and training.

Main Responsibilities:

• Acts as primary local company contact for assigned sites for specific trials

• May participate in site feasibility and/or pre-trial site assessment visits

• Attends/participates in investigator meetings as needed

• Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring, site management and site/study close-out.

• Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.

• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.

• Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.

• Ensures site staff complete data entry and resolve queries within expected timelines.

• Ensures accuracy, validity and completeness of data collected at trial sites.

• 
  A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field is required.

• A minimum of 2 years of clinical trial monitoring experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.

• Specific therapeutic area experience may be required depending on the position.

• Strong working knowledge of GCP, company SOPs, 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 overnight stay away from home.

Language Requirements:

• Dutch & English & French

What’s in it for you…?

“Caring for the world, one person at a time…”

As an employee we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future! We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.