J&J Family of Companies Senior Site Manager (5 Openings) in Jefferson City, Missouri
Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for Senior Site Managers based remotely within the United States.
Johnson & Johnson Medical Devices currently grossing $20 billion in World Wide sales, is expected to experience solid growth over the next 5 to 7 years. Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products.
On behalf of the Medical Device Group, The Senior Site Manager (Senior SM) serves as the primary contact point between the Sponsor and the Investigational Site. The Senior SM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with site selection, pre-trial assessment, subject recruitment, retention planning, site initiation, on-site and remote monitoring and close-out activities. The Senior SM will partner with the Clinical Trial Leader (CTL) to ensure overall site management while performing trial related activities for assigned protocols. The Senior SM may contribute to process improvement, training and mentoring of other Site Managers.
Key Job Activities:
Principal Clinical Study Site Management Tasks
Act as primary local company contact for assigned sites for specific trials.
May participate in site feasibility and/or pre-trial site assessment visits
Attend/participate in investigator meetings as needed.
Execute 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 and policies.
Ensure site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
Work in close collaboration with CTL for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe.
Ensure site staff completes data entry and resolves queries within expected timelines.
Ensure accuracy, validity and completeness of data collected at trial sites
Ensure that all Adverse Events (AEs) /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 data collected and information within the source documents.
Maintain complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
Fully document trial related monitoring activities. Writes visit reports and follow-up letters in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
Review study files for completeness and ensures archiving retention requirements are met; including storage in a secure area at all times.
Collaborate with the CTL in documenting and communicating site/study progress and issues to trial central team.
Attend regularly scheduled team meetings and trainings.
Comply with relevant training requirements. Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support role and responsibilities.
Work closely with CTL 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.
Prepare trial sites for close out and conduct final close out visit.
Establish and maintain good working relationships with internal and external stakeholders, investigators, trial coordinators and other site staff.
Act as a point of contact in site management practices.
May be assigned as a coach and mentor to a less experienced site manager.
May contribute to process improvement and training.
Lead and/or participate in special initiatives as assigned.
May 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.
A Bachelor’s Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science with at least 2 years of relevant experience or a Masters or PhD/MD/PharmD with at least 1 year of relevant experience.
Previous clinical research experience required.
Previous medical device monitoring or equivalent experience required.
Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
Clinical/medical background – a plus.
Strong computer skills in appropriate software and related company clinical systems is required
Excellent written and oral communication skills
Strong organizational skills (e.g., able to manage multiple sub-projects and tasks simultaneously and consistently meet all associated deadlines).
Willingness to travel 50%, approximately 2-3 days per week, with overnight stays (1-2 nights on average), is required
A valid Driver’s License issued in one of the 50 United States, and a good driving record is required.
United States-New Jersey-Somerville-
North America-United States
Depuy Orthopaedics. Inc. (6029)
Clinical Trial Administration