Clinical Study Manager
This is a fantastic job opportunity for a Clinical Study Manager to be based in London. This is an international organisation with over 1300 employees, they specialise in the development and commercialisation of innovative biopharmaceuticals.
The Sr. Trial Specialist role within Global Medical Affairs (GMAF) Study Management & Data Analytics (SMDA) is an independent, experienced site management and oversight role for assigned trial(s). Responsibilities focus primarily on oversight of vendor CRAs and mentoring of more junior staff, as well as study/site start-up, maintenance and close-out activities, co-monitoring, and management of other vendors.
The individual in this role exhibits foundational level skills related to communication, leadership, strategic thinking, adaptability, flexibility, drug development, and therapeutic area knowledge. S/he has advanced technical skills related to compliance.
- Manage site budget and contract negotiation, payment, and processing activities in collaboration with the Study Manager, Legal, and Finance
- Participate in the selection of vendors, support Study Manager in oversight of vendors across assigned trial(s); may include contract negotiation, change orders, budgeting, and meeting facilitation
- Collaborate with medical science liaisons (MSLs) and/or regional medical directors to support sites as appropriate
- Responsible for development of site enrolment plans, start-up materials, informed consent document templates (ICD), and other trial related plans (e.g. monitoring plan)
- Participate in the preparation and finalization of protocols, clinical study reports, and interim reports
- Responsible for the final review of the site level documentation and approval for initiation
- Liaise with supply chain for investigational product forecasting at the site level, including shipment and reconciliation activities
- Responsible for ensuring all supplies required for trial participation by sites are available
- Responsible for implementation of site feasibility, selection, activation, training, maintenance and close-out activities
- Responsible for implementation of trial plans for site oversight according to the monitoring plan
- Communicate with field CRAs and site staff for timely data collection and query resolution
- Oversee site documentation activities (TMF reconciliation, filing, and archiving)
- Responsible for adherence to timelines and quality at a site level for assigned trial(s)
- Partner with Data Management to coordinate and participate in data reviews to ensure data collection and query resolution occur in a timely manner
- Collaborate with Pharmacovigilance and Medical Monitor on reconciliation of clinical and safety data
- Identify and anticipate problems at a site level in collaboration with Field CRAs throughout the life of the trial (i.e., investigator disengagement)
- Responsible for implementation of corrective and preventative actions resulting from a site audit
- Identify potential protocol deviations and escalate per protocol deviation plan
- Train, mentor and support junior staff supporting assigned trials, if assigned
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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