Senior Clinical Site Manager

3 weeks ago

Raleigh, North Carolina, United States UCB Full time

Make your mark for patients

Maximizing site performance and site engagement in UCB conducted clinical studies. Leveraging strong clinical operational and therapeutic expertise (scientific, clinical, disease states, and treatment alternatives knowledge within the therapeutic area(s)) to support execution of the clinical studies.

Responsible for the planning, initiation, coordination and management of all monitoring and monitoring-related activities as well as supervision of all site-related activities to ensure compliance with UCB Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and regulatory requirements. Engages with clinical sites to develop, build, and maintain strong relationships with investigators/staff that will ensure high quality investigative sites to support UCB's clinical development programs. Collaborate with internal and external stakeholders as well as third party vendors. Provide operational support to the CPM/Sr CPM to deliver the study within planned timelines and according to required standards of quality and compliance. Evaluate, screen and develop high quality investigative sites to support UCB's clinical development programs.

Site Engagement Deliverables:

  • Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the UCB Clinical Team and key internal stake holders throughout the life cycle of UCB clinical trials
  • Support UCB clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial hurdles and using motivational tactics to ensure timely delivery of UCB trials
  • Engage, evaluate and develop a global network of high performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of UCB and its activities thereby increasing their desire to partner with UCB
  • Develop & maintain relationships with site engagement organizations; assist in identification of high performing sites and key opinion leaders that can contribute to UCB forums, boards and/or discussions
  • Interact/train new investigators to work on UCB clinical trials

Monitoring Deliverables:

  • Responsible for all kinds of site visits (e.g. Selection / Initiation / Monitoring / Close-out / Motivational / Support) and sites' performance regarding set-up, conduct and data collection
  • Primary contact for sites regarding study-related issues.
  • Responsible for the early engagement with Key Opinion Leaders (KOLs)/ sites / patients organizations and key contact point for these throughout the study.
  • Interact/train new investigators to work on UCB clinical trials.
  • Attend key therapeutic trainings/meetings and/or industry trainings.
  • Support CPM in management of the study, including but not limited to:
    • Vendor management
    • Training
    • Logistic
    • Selection of sites
    • Maintenance of study tracking
    • Oversight of eTMF
  • Close cooperation with the Clinical Project Managers and members of the Clinical Trial Teams to inform on all aspects of the clinical trial status at site.
  • Ensure appropriate engagement and communication with internal stakeholders regarding site visits and related activities.
  • Support the development of key study documents including, but not limited to Case Report Form (CRFs), diaries, informed consent/participant information, the study concept and protocols/amendments including presentations and Investigator Meetings or other trial-related meetings.
  • Prepare and/or review monitoring tools, e.g. monitoring manual
  • Support CRO/vendor selection activities and provide input in development of contract specifications regarding monitoring activities for clinical trials.
  • Review and approval of site regulatory packages
  • Prepare or review responses to questions from Regulatory Authorities and IRBs/ECs.
  • Contributes to updates of clincial program information, e.g., annual safety updates, Investigator's Brochure, and on query resolution, as needed, etc.
  • Depending on trial setting:
  • Train appropriate internal and CRO personnel on trial-specific monitoring requirements.
  • Track monitoring activities including review of regulatory package status, visit reports, queries (nature and frequency), and ensure timely collection of the data.
  • Conduct co-monitoring visits with internal or CRO personnel to ensure quality of trial and initiate corrective actions where appropriate.
  • Utilising all applicable Decentralised Clinical Trial (DCT) methods.
  • Shares insights, innovation opportunities and patient needs internally to the team, through collaboration with the UCB innovation/Technology Transformation Implementation (TTI) Teams.
  • Such other responsibilities and projects that the Company may assign, e.g., cooperation on SOPs.
  • In collaboration with CPM/study team, ensure that the study is audit/inspection ready at all times and any resulting findings from audits/inspections are addressed appropriately and in a timely manner.

Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US- for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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