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We have amazing people - smart, experienced and united by a desire to change the course of medical science worldwide for patients and caregivers alike.
Worldwide Clinical Trials is seeking an experienced Site Activation Leader (Manager to Associate Director level) to join our global team! This role can be based anywhere in the CIS or any EU Country.
The Senior Manager, Site Activation and Feasibility provides senior oversight of Site Activation Specialists who are responsible for feasibility and Site Identification and Activation, Central and Local Ethics submission and approval processes, ICF review / customization, and collection and quality review of ICH GCP essential documents to enable site activation.
RESPONSIBILITIES : Tasks may include but are not limited to : Manage the Site Activation team (local Specialists, Regulatory Affairs, Sites Contracts and Regulatory Compliance) Coordinate and drive the activities of the Site Activation in conjunction with the Site Management department to achieve on time site activations.
Oversee the activities of assigned Site Activation Specialists to ensure critical path activities completed on time. Coordinate with other Site Activation Leaders to prioritize country level activities across projects and ensure the optimal start-up of all projects in the start-up phase.
Serve as the primary point of accountability and contact for all start-up activities on assigned project. Work closely with the assigned LCRA and GPL to expedite the Site Qualification and Selection process as appropriate.
Coordinate and provide project level status reporting to GPL and Sponsor as appropriate. Perform and prepare risk assessment and mitigation plans relating to departmental deliverables Work in conjunction with the assigned LCRA and GPL to develop study-specific Site Activation Plan which includes all activities required to activate sites for a specific study ensuring each task has a clear owner and due date.
Liaise with other functional contributors and vendors as needed. Develop, review, maintain SOPs and best practice guidelines and provide training pertaining to activities of the Site Activation department.
Lead / provide input to departmental process improvement initiatives. Support the sales process by contributing to proposals and bid defence meetings.
BENEFITS : Worldwide offers a host of benefits for all fulltime associates around the globe EOE : Worldwide welcomes and appreciates all backgrounds and is an Equal Opportunity Employer (EOE) #UncommonCRO #UncommonTalent #L1-JM1 Description Key Responsibilities Benefits