Site Activation and Regulatory Lead

Location: Nottingham, England, United Kingdom

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Requisition Number: 339

Position Title: Site Activation and Regulatory Lead

External Description:

SUMMARY: Accountable for end-to-end site activation activities for assigned projects and responsible for all activities of the Site Activation department.  This includes coordinating and overseeing site identification, investigator and site contracts, central and local EC submissions, Competent Authority submissions and any other country and/or study specific requirements or activities necessary for Site Activation in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs).RESPONSIBILITIES:Tasks may include but are not limited to:  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 deliverablesEscalate issues to functional units as necessary to ensure resolution and minimize risks to on-time 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.Collation and maintenance of site activation metrics. Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. OTHER SKILLS AND ABILITIES:   Strong oral and written communication skillsStrong planning and organizational skills with effective time managementStrong interpersonal skillsDemonstrated ability to collaborate across the businessStrong Ability to work in an organized, methodical and self-motivated mannerStrong understanding of clinical research principles and processStrong understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirementsAbility to proactively identify and solve problemsStrong understanding of standard operating proceduresProficient knowledge of Microsoft Office and other contemporary software applications  REQUIREMENTS:  A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, ORTwo-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and eight year’s experience within clinical research (e.g. CRA, Reg Affairs.)Required CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experienceProficient in cross-cultural communicationProficient in both spoken and written English  Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.  

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Employment Type: Regular

Community / Marketing Title: Site Activation and Regulatory Lead

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Rome, IT

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