Site Manager

Global Clinical Operations (GCO)
**Site Manager I**

Position Summary:
**The main duties and responsibilities of the position are**:

- 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 (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.
- Ensures site staff are trained and the corresponding training records are complete and accurate at any

time point during all trial phases. Responsible in close collaboration with LTM and central study team

for the activities during site activation phase in order to speed up the process and activate the site in

shortest possible timeframe.
- Contributes to site level recruitment strategy and contingency planning and implementation in

partnership with other functional areas.
- Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for

trial conduct.
- Ensures that clinical drug supplies are appropriately used, handled and stored and returns are

accurately inventoried and documented.
- Arranges for the appropriate destruction of clinical supplies.
- Ensures site staff complete data entry and resolve queries within expected timelines.
- Ensures accuracy, validity and completeness of data collected at trial sites
- Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs )/Product Quality Complaints

(PQCs) are reported within the required reporting timelines and documented as appropriate. For

AEs/SAEs, ensures that they are consistent with all data collected and with the information in the

source documents.
- Maintains complete, accurate and timely data and essential documents in relevant systems utilized

for trial management.
- Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up

letter in accordance with the SOPs. Promptly communicates relevant status information and issues

to appropriate stakeholders.
- Reviews study files for completeness and ensures archiving retention requirements are met, including

storage in a secure area at all times.
- Collaborates with LTM for documenting and communicating site/study progress and issues to trial

central team.
- Attends regularly scheduled team meetings and trainings.
- Complies with relevant training requirements. Act as local expert in assigned protocols. Develops

therapeutic knowledge sufficient to support role and responsibilities.
- Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for

Quality Assurance (QA) site audits and for quality issues identified at the site during routine

monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
- Prepares trial sites for close out, conduct final close out visit.
- Tracks costs at site level and ensure payments are made, if applicable.
- Establishes and maintains good working relationships with internal and external stakeholders in

particular investigators, trial coordinators and other site staff.
- May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as

required/appropriate.
- Acts as a point of contact in site management practices.
- May contribute to process improvement and training.

gifts

**Qualifications**
Education and Experience Requirements**:

- A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
- 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.
- Proficient in speaking and writing the country language and English. Good written and oral communication.

gifts

**_For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
- **

**_We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences_**

**_