Associate Clinical Operations Leader - FSP

Are you looking for commitment and opportunity to inspire purposeful contribution?

ExecuPharm a PAREXEL company is a contract research organization (CRO) that provides clinical research support services to companies from the pharmaceutical industry.

The company has more than 18,000 global clinical operational specialists in its network and it is one largest privately-owned global diversity suppliers of clinical development services since 1994.

Lead Clinical Research Associates or Senior CTA’s that have provided extensive project management support or similar experience would be considered for the role.

The ACOL position is responsible for supporting study and site management activities and may include coordination, administration, or management of specific trial activities & management of client clinical trial sites. This role focuses on performing all activities required to evaluate, initiate, monitor and close clinical trial sites. Assist, or may lead Clinical Trial Management effort to develop, review and track study documents, including, ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan and Research Specimen Manuals. Ensure the Clinical Trial Master System (CTMS) and Trial Master File (TMF) are maintained in an inspection-ready state. Track site and study status as assigned. Assess adequacy of potential clinical investigators and clinical trial sites. Includes evaluation of facilities, personnel, patient referral base, and adherence to GCP/ ICH. Train clinical investigators and their personnel regarding clinical trial protocol and regulatory requirement. Collect and review site essential documents, including site Informed Consent Form (ICF) changes Act as a primary contact with field CRAs, Contract Research Organizations (CROs), vendors, and multiple clinical trial sites. Monitor compliance with the clinical trial protocol, CFR, GCP/ICH guidelines, and overall protocol objectives Asist with management and accountability of clinical trial supplies. Assist with management of clinical trial safety and efficacy issues, including, but not limited to review and follow-up of Serious Adverse Event reports. Assist in the preparation and follow-up of in-house and on-site Client sponsored quality audits, as well as, regulatory authority inspections. Conduct clinical team meetings, including agenda preparation, minutes, and action item tracking as assigned Ensure appropriate CRF completion and review and approval of clinical trial site monitoring reports. Qualifications

Experience of supporting sites across multiple EU countries is essential. Applications without this will not be considered. Experience in all aspects of the duties listed below is also required. Study Start Up. Finance (invoices & investigator payments). Clinical Supplies. Site Support. Document Management.