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Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Support

Job Category:

Professional

All Job Posting Locations:

Warsaw, Masovian, Poland

Job Description:

Position Summary:

As a part of Purposeful Ecosystem, Lead SM will work to implement the Purposeful Site Management strategy. The main goal is to make Johnson & Johnson a Sponsor of Choice within our Key Sites. The main focus should be on:

• Gaining and presenting sufficient knowledge regarding the specifics of Key Sites, Investigators, and their needs, conducted clinical trials and J&J portfolio.

• Building and maintaining lasting relationships based on collaboration and mutual value.

• Supporting timely study goals achievement (study start-up, patient recruitment, DBLs, regulatory requests, audits/ inspections, etc.). This should be more strategic than operational support; however operational help is not excluded from the scope of duties.

• Being site first contact in case of general issues with (but not limited to): quality of cooperation with J&J, relationship/ communication, contracts, payments, vendors, PTA. Building contact networks to effectively support sites and relevant stakeholders.

• Ensuring effective oversight to identify potential risks and maintain satisfactory quality of conducted studies.

• Analyzing key sites needs and providing personalized solutions.

• Supporting the introduction of new technologies at sites to improve smooth study conduct and data collection.

• Supporting development of the portfolio/ molecule by participating in protocol simulation meetings.

• Performing portfolio landscape analysis/site profile of key sites (PI profile - experience, conducted studies, sites expectations, previous recruitment rate, patients’ population)

A Lead Site Manager is considered as the most senior site management role with typically more than 6 years of experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. Additionally, a Lead Site Manager is generally expected to have outstanding capability to engage with key sites and their respective personnel. A Lead 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 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. A Lead Site

Manager is expected to lead process improvements at country, regional, and global levels as well as training and mentoring of other Site Managers. A Lead, Site Manager is expected to operate independently and be able to perform clinical trial tasks proficiently and is expected to identify opportunities for streamlining processes. Additionally, a Lead Site Manager is expected to oversee, train and mentor more junior Site Managers when required. Lead Site Manager can

support leadership at a study level as requested.

Principal Responsibilities:

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

2. Actively participate and provide in-depth insights in site feasibility and/or Site Qualification Visit.

3. Leads investigator meetings as needed. Presents study updates and facilitates discussions between meeting participants.

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. 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.

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. Expected to anticipate obstacles and proactively look for solutions and share practices with other sites to accelerate start up and mitigate against study issues.

6. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas. May be required to support LTM in drafting country level recruitment strategy and contingency planning.

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. 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.

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

18. Complies with relevant training requirements. 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.

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). May be required to oversee audit and inspection preparation by Associate SM.

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. May be required to support LTM in tracking costs across sites at the country level.

22. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. May be required to prepare communications to all sites within the country. May be required to function as Site Engagement Lead across studies at a site.

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. Able to provide authoritative insights, expert advice and share best practices

25. Will routinely be assigned as a coach and mentor to a less experienced site manager.

26. Expected to contribute to process improvement and training.

27. Routinely requires to leads and/or participates in special initiatives as assigned.

28. Will routinely be expected to assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”.

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

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).

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 by the hiring manager when considering the candidate’s eligibility.

• 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.

• 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.

• 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.

The anticipated base pay range for this position is 210,000 PLN to 402,500 PLN.

In addition to base pay, we offer the following benefits: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

 

 

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