Associate Site Manager, Global Clinical Operations - 2406216856W

Description

Johnson & Johnson is currently seeking an Associate Site Manager to join our Global Clinical Operations team located in Bandar Sunway.

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 https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the worlds most pressing healthcare challenges.

We know that the success of our business and our ability to deliver meaningful solutions depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Position Summary:

• An Associate, Site Manager is an entry level site management role with typically 0-2 years of experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. An Associate, Site Manager is assigned to trial 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 guidelinesfrom 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 Associate, 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 forassigned protocols. May contribute to process improvement and training. Some supervision from a more Senior, Site Manager (Senior SM or Lead SM) to help provide guidance toAssociate, Site Manager.

Principal Responsibilities:

1. Acts as primary local company contact for assigned sites for specific trials.

2. May participate in site feasibility and/or Site Qualification Visit.

3. Attends/participates in investigator meetings as needed.

4. 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. Occasionally may require assistance or oversight from Lead, Site Manager or LTM.

5. 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.

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

7. Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.

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

9. Arranges for the appropriate destruction of clinical supplies.

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

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

12. 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.

13. Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management.

14. 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.

15. Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.

16. Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.

17. Active participation in regularly scheduled team meetings and trainings. Provide feedback as appropriate. May be asked to lead/provide leadership at these meetings.

18. Complies with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.

19. 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. Compliance Monitoring Visit (CMV).

20. Prepares trial sites for close out, conduct final close out visit.

21. Tracks costs at site level and ensure payments are made, if applicable.

22. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.

23. May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.

24. Acts as a point of contact in site management practices.

25. May contribute to process improvement and training.

Principal Relationships:

• Primary Reporting Structure: Reports to a FM/CRM

• Primary interfaces: FM/CRM, CTA, LTM and TDL

• Other Internal Interfaces: R&D Country Head, Therapeutic Area Manager/Physician, Compliance Managers/Specialists, Training Manager, Contracts & Centralized Services (CCS), Local Safety Officer (where required) and Site Manager team.

• External Interfaces: Investigators and their delegates at site (trial site personnel).

Qualifications

• A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences, or related scientificfield (or equivalent experience) is required.

• A minimum of 1 year of clinical trial monitoring experience is required. 1-2 years of clinicaltrial monitoring experience is preferred. However, other relevant experiences and skills maybe considered by the hiring manager when considering the candidates eligibility.

• Specific therapeutic area experiences an added advantage.

• Basic working knowledge of GCP, company SOPs, local laws, and regulations, assignedprotocols 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 oralcommunication.

Primary Location Asia Pacific-Malaysia-Selangor-Petaling Jaya

Organization Johnson & Johnson Sdn. Bhd. (8275)

Job Function Clinical Trial Support

Req ID: 2406216856W