Site Activation and Regulatory Lead/Sr. (Remote, United States)

Location: Morrisville, North Carolina, United States

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Requisition Number: 995

Position Title: Site Activation and Regulatory Lead

External Description:

Site Activation is a fast growing, dynamic department!  We are the launch pad for new projects.  We help determine strategies for the optimal mix of countries, target sites and other factors to expedite regulatory and recruitment objectives, and then execute that strategy by initializing regulatory filings and locating, qualifying and activating clinical research sites.

The Site Activation group is the perfect place to launch or further your career.  We emphasize development of project management and strategic planning skills that will advance you though the opportunities within Site Activation or serve as an excellent pathway to advancement in Project Management or other Clinical Operations groups. 

The Site Activation and Regulatory Lead is accountable for end-to-end site activation and regulatory activities for assigned projects in the Site Activation and Regulatory (SAR) department. This includes line management of SAR support roles and project teams. Activities include 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). It may also include proposal and budget management or feasibility/site identification activities. Reports to the Site Activation and Regulatory Therapeutic Lead.

RESPONSIBILITIES:

Tasks may include but are not limited to: 

  • Serve as the primary point of accountability and contact for all start-up activities on assigned projects
  • Lead and manage assigned SAR project teams to achieve successful delivery of milestone achievements and any key performance indicators   
  • Perform line management activities; responsible for direct report performance, development and administrative compliance
  • Provide knowledgeable regulatory advice and contribute to regulatory project work
  • Oversee the activities of assigned Regulatory Affairs Specialists and Site Activation Specialists to ensure critical path activities completed on time
  • Ensure accurate compilation, management and tracking of site activation activities in timely manner
  • Work closely with the assigned team members to expedite the Site Qualification and Selection process as appropriate
  • Effectively communicate Site Activation & Regulatory project status to the Sponsor, GPL/CPM and project team
  • Perform and prepare risk assessment and mitigation plans relating to departmental deliverables
  • Work in conjunction with the assigned LCRA and GPL to develop the 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/coaching pertaining to activities of the Site Activation department
  • Lead/provide input to departmental process improvement initiatives
  • Interpret site activation metrics and drive corrective action to achieve deliverables or milestones and KPIs
  • May participate in business development activities by contributing to proposals and bid defense meetings by preparing regulatory sections of proposals and feasibility reports, regulatory costing and budgets, contracting process, ED process, and other country and/or study specific requirements or activities necessary for Site Activation
  • Report and/or escalate issues to Site Activation & Regulatory Therapeutic Lead as necessary to ensure resolution and minimize risks to on-time deliverables
  • Remain currently knowledgeable of changing regulatory legislative requirements of the regulatory intelligence database
  • Comply with SOPs, ICH GCP and national regulations as applicable
  • Review and make recommendations on all relevant study regulatory documentation e.g. labels, patient information sheets, diary cards etc. to ensure compliance with ICH GCP & country specific requirements
  • Foster professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers
  • Contribute towards the preparation of technical /master study documentation
  • May lead or support feasibility or site identification activities
  • Liaise with other functional contributors and vendors as needed
  • Strong leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing
  • Ability to exercise sound judgment and make decisions independently and to proactively identify and solve problems
  • Ability to provide experience and input into initiatives relating to interacting with sites and/or customers
  • Ability to motivate, lead and engage a team
  • Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
  • Strong oral and written communication skills to clearly and concisely present information
  • Demonstrated ability to collaborate across the business
  • Team-oriented work style; seeks and gives guidance
  • Understanding of regulatory processes, guidelines, and the application of local regulatory requirements
  • Understanding of initiation, planning, and execution of clinical projects and overall project planning
  • Thorough knowledge of ICH GCP Guidelines and the FDA/ EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)
  • Ability to handle multiple tasks in a fast-paced and constantly changing environment
  • Ability to work in an organized, methodical and self-motivated manner
  • Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude

REQUIREMENTS:

  • A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR…
  • Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and eight years’ experience within clinical research (e.g. CRA, Reg Affairs.)
  • Minimum of 3 years CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experience
  • Proficient in cross-cultural communication
  • Proficient in both spoken and written English

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City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Site Activation and Regulatory Lead/Sr. (Remote, United States)

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.

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