Kelly Science and Clinical FSP is currently seeking a Sr Site Manager for a long-term engagement with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
JOB GOAL: Site Management services provides Trial Co-ordination and Site Management services as primary point of contact between the sponsor and the investigational site. Services/deliverables include ensuring trial sites are inspection ready through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), applicable regulations from start-up through data-base lock. Further, services/deliverables will include pre-trial assessment, site selection, subject recruitment and retention planning, site initiation, monitoring and close-out. Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Local Trial Manager (LTM) and Central Trial Manager (CTM)/Global Trial Manager (GTM) to ensure overall site management while performing trial related activities for assigned protocols.
Services rendered will adhere to applicable to client’s SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
Complies with relevant training requirements.
Contribute to quality Site Selection through participation in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team, as required.
Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial (investigator meetings, site visits, quality communication, etc.).
Drive study compliance by executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies. Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
Ensures site is equipped to carry out the trial with adequate site study supplies (such as Non-IP, lab kits, etc.) and clinical drug supplies. This will include oversight of proper handling, storage and return and/or destruction with accurate inventory maintained/documented.
Ensures quality data (accurate, valid, and complete) is provided by the site and queries resolved within expected timelines.
Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate, with supporting data collected and verifiable with information in the source documents.
Ensures Inspection readiness for sites by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g., CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements, including storage in a secure area at all times.
Focuses on Investigator engagement through timely follow up with sites. Completes follow-up letter to communicate relevant information and required corrective action to the investigator and his/her team with 15 working days. Promptly communicates relevant status information and issues to appropriate stakeholders. Follows the corresponding Monitoring Guidelines for each assigned trial.
Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements and developing therapeutic knowledge sufficient for role and responsibilities.
Works closely with LTM to ensure CAPA is completed for 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).
If applicable, will support negotiation of investigator budgets at site level, support tracking of costs and ensure payments are made at site level, maintaining site relationships.
May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.
May contribute as a mentor to a less experienced site manager or to process improvement and training, as appropriate for business needs.
Ensure timely and accurate CTMS data entries / updates.
SMs may also take the role of Independent Drug Monitor (IDM) once additional training is completed and as required by individual trial.
If applicable, region specific deliverables will be specified.
Autonomy in execution of site management services
Depth of knowledge with site management services
BA/BS degree/Degree in a health or science related field or equivalent industry experience
2 years of clinical trial monitoring experience or equivalent industry experience and completion of a monitoring training course
Specific therapeutic area experience depending on the services need
Strong working 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 overnight stay away from home according to business needs.
Proficient in speaking and writing in English and the country language where services will be provided. Effective communication skills, oral and written.
Experience with monitoring and site management of complex Early Phase of clinical development, as applicable.
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