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Senior Site Activation Manager - Europe - Remote

Worldwide Clinical Trials - USA
Bucharest, Bucharest, United States;Homeworking
Start date
1 Oct 2022
Closing date
30 Oct 2022

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Project Management
Full Time
Contract Type
Experience Level
Experienced (non-manager)
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Job Details

SUMMARY: This is a seasoned leadership role accountable for site activation project management and delivery in the Site Activation and Regulatory (SAR) department. Project activities include site identification, investigator and site contracts, central and local EC submissions, Competent Authority submissions and any other country and/or study specific 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 or may report to a Site Activation Portfolio Manager if assigned to a portfolio or program of studies

  • Serve as the primary point of communication and accountability for start-up and maintenance (if applicable) activities on assigned projects
  • Lead and manage assigned SAR project teams to achieve successful delivery of milestone achievements and any key performance indicators
  • May perform line management activities with; responsibility for direct report performance, development and administrative compliance
  • Oversee project activities of Regulatory Affairs Specialists and Site Activation Specialists to ensure critical path activities completed on time
  • Ensure accurate compilation, management, tracking and analysis of site activation activities in timely manner
  • Work closely with assigned team members to expedite the Site Qualification and Selection process
  • Effectively communicate Site Activation & Regulatory project status to the Sponsor, GPL/CPM and project team
  • Lead risk assessment and mitigation plans relating to departmental deliverables with input from other roles
  • Work with and lead project team members to develop site activation related project plans, such as 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.
  • Help develop, review, and 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
  • Recommend, establish and interpret site activation metrics; drive corrective action to achieve deliverables, milestones and KPIs
  • May participate in business development activities by contributing to proposals and bid defense meetings by preparing relevant sections of proposals budgets, and other country and/or study specific activities related to 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
  • Comply with SOPs, ICH GCP and national regulations as applicable
  • May lead or support feasibility or site identification activities
  • Liaise with other functional contributors and vendors as needed

  • Proven leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing
  • Demonstrated ability to exercise sound judgment and consistently make decisions independently to proactively prevent and solve problems
  • Demonstrated ability to consistently positively impact initiatives relating to interacting with sites and/or customers
  • Demonstrated ability to motivate, lead and engage a team to consistently and successfully achieve meaningful goals
  • Demonstrated ability to perform and thrive in ambiguous situations
  • 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
  • Thorough understanding of regulatory processes, guidelines, and the application of local regulatory requirements
  • Thorough understanding of initiation, planning, and execution of clinical projects and overall project planning
  • Thorough awareness of ICH GCP Guidelines and the FDA/ EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)
  • Demonstrated ability to handle multiple tasks in a fast-paced and constantly changing environment
  • Demonstrated 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

  • A minimum four-year college curriculum or equivalent 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 four years’ experience within clinical research (e.g. CRA, Reg Affairs.)
  • Plus a minimum of 7 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

#LI-MP1 #LI-Remote


We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 2,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Find Us
600 Park Offices Drive
Suite 200
Research Triangle Park
NC 27709
United States
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