Senior Site Manager (Clinical Research Associate)

2+ years

Not Disclosed

Remote, USA

10 Aug. 21, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About the Role:
As a Senior Site Manager, you will serve as the primary liaison between the Sponsor and the Investigational Site, ensuring compliance with clinical trial protocols, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and all relevant regulations and guidelines. Your responsibilities will span the entire study lifecycle, from site start-up through to closure. You will collaborate closely with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and Clinical Trial Manager (CTM) to oversee site management and execution of trial-related activities. Additionally, you may contribute to process improvements, training, and mentoring of other Site Managers.

Key Responsibilities:

Serve as the primary local contact for assigned trial sites.
Participate in site feasibility studies and pre-trial assessments as needed.
Attend and participate in investigator meetings.
Oversee site initiation, start-up, monitoring (including remote monitoring), and close-out activities in accordance with SOPs, Work Instructions (WIs), and company policies.
Implement and monitor an analytical risk-based approach at the site level, ensuring timely resolution of issues.
Ensure site staff are adequately trained, with complete and accurate training records throughout all trial phases.
Collaborate with the LTM and central study team during site activation to expedite the process.
Contribute to site-level recruitment strategies and contingency planning.
Ensure that clinical drug supplies are used, handled, stored, and documented appropriately, including overseeing the destruction of clinical supplies when necessary.
Ensure timely and accurate data entry and query resolution by site staff.
Maintain the accuracy, validity, and completeness of data collected at trial sites.
Report all Adverse Events (AE), Serious Adverse Events (SAEs), and Product Quality Complaints (PQCs) within required timelines, ensuring consistency with collected data and source documents.
Maintain comprehensive and timely documentation of trial-related activities, including monitoring visit reports and follow-up letters.
Ensure study files are complete and meet archiving retention requirements, with secure storage at all times.
Collaborate with the LTM to document and communicate site/study progress and issues to the trial central team.
Attend regular team meetings and complete required training.
Act as a local expert in assigned protocols, developing sufficient therapeutic knowledge to support the role.
Work with the LTM to ensure the completion of Corrective Action Preventative Action (CAPA) for Quality Assurance (QA) site audits and quality issues identified during monitoring.
Prepare trial sites for close-out and conduct final close-out visits.
Track site-level costs and ensure payments are made where applicable.
Establish and maintain positive working relationships with internal and external stakeholders, including investigators, trial coordinators, and other site staff.
Participate in Health Authority (HA) and IEC/IRB submission and notification processes as required.
Serve as a point of contact for site management practices.
Mentor and coach less experienced Site Managers.
Contribute to process improvements and training initiatives.
Lead or participate in special initiatives as assigned, potentially serving as a “Champion” or Subject Matter Expert.

Qualifications:

Education: A minimum of a BA or BS degree in Life Sciences, Nursing, or a related scientific field (or equivalent experience).
Experience: A minimum of 2 years of clinical trial monitoring experience is preferred, though other relevant experience and skills may be considered.
Specific Skills:
- Strong knowledge of GCP, company SOPs, local laws, and regulations.
- Proficiency in relevant IT systems and software.
- Strong written and oral communication skills in both English and the local language.
Other Requirements:
- Willingness to travel, including occasional overnight stays.
- Therapeutic area experience may be required depending on the position.

About Johnson & Johnson:
At Johnson & Johnson, we believe in the power of health to transform lives. We leverage our strength in healthcare innovation to build a world where diseases are prevented, treated, and cured, with treatments that are smarter, less invasive, and more personalized. Our expertise spans Innovative Medicine and MedTech, allowing us to deliver healthcare breakthroughs that profoundly impact humanity. Learn more at Johnson & Johnson.

Equal Opportunity Employer:
Johnson & Johnson is committed to creating a diverse and inclusive environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.

For more information on how we support the well-being of our employees throughout their wellness, career, and life journey, visit Johnson & Johnson Careers.

If you require a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, or to receive other benefits, please contact us to request assistance.