Site Activation Manager
- Europe/US
- Remote Worldwide Clinical Trials
- 2.
7 Durham, NC Job Details Full-time 1 day ago Qualifications Project team coordination Project reporting Nursing Budget management Microsoft Excel Budget control English Mid-level Organizational management Business development ICH guidelines Bidding project phase Proposal writing Clinical research compliance Bachelor's degree Continuous improvement Scope management Research regulatory compliance Productivity software 4 years Cross-functional collaboration Escalation handling Cross-functional team management Leadership Communication skills Project stakeholder communication Regulatory compliance management Cross-functional communication Progress tracking (project management tasks) FDA regulations Full Job Description Who we are 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 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs
- in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What the Site Activation Manager does at Worldwide Clinical Trials The Site Activation Manager is accountable for site activation project management and delivery activities within the CNS therapeutic area. Responsibilities include coordination, collaboration, and oversight of site identification and central and local ECs (for NA countries only) activities, progression of essential documents collection, monitoring of investigator and site contracts status, and any other country and/or study-specific site activation tasks necessary for Site Activation in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). May also include pre-award support by providing site activation-related input into the proposal text and budget items. Reports to a senior member of the Site Activation leadership team within the assigned therapeutic area. What you will do Serve as the primary point of accountability for site activation and start‑up activities on assigned studies. Oversee cross‑functional site activation activities to ensure milestones are achieved on time and within budget. Manage the accurate tracking, analysis, and reporting of site activation progress and metrics. Partner with project teams to support feasibility, site qualification, selection , and regulatory activities as needed. Communicate site activation status, risks, and mitigation plans to Sponsors , project leadership, and internal teams. Develop and maintain site activation project plans and support risk assessment and issue resolution. Ensure site activation activities are appropriately budgeted, with out‑of‑scope work tracked and managed through change control. Drive continuous improvement through SOP development, best practices, metrics, and departmental initiatives. Contribute to business development activities, including proposal development and bid defense support. Liaise with internal stakeholders and external vendors, escalating issues as needed to ensure on‑time delivery. Ensure compliance with SOPs, ICH GCP, and applicable regulatory requirements. What you will bring to the role Strong leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing Ability to provide experience and input into initiatives relating to interacting with sites and/or customers Strong interpersonal , oral and written communication skills in a fast-paced, deadline-oriented, and changing environment Demonstrated ability to collaborate across the business Team-oriented work style: seeks and gives guidance Understanding of regulatory processes and guidelines Understanding of initiation, planning, and execution of clinical projects and overall project planning Awareness of ICH GCP Guidelines and the FDA/EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications) Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude Your experience A minimum four-year degree or nursing degree is required Minimum of 4 years CRO experience in Study Start-Up with country lead or manager experience required Proficient in cross-cultural communication Proficient in both spoken and written English We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at Discover a world of difference at Worldwide ! For more information on Worldwide, visit www.
Worldwide.com or connect with us on LinkedIn . Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law .
