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

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.