Senior Clinical Project Manager

Make your mark for patients

We are looking for a Clinical Project Manager who is an integral part of the PV Development Solutions / GCSO team, a dynamic and diverse group of professionals who are committed to delivering value to patients, manage global clinical studies with large budgets and multiple vendors, to join us in our Global Clinical Science & Ops team, based in our Raleigh, NC office. Our teams operate in a hybrid model.

About the role

The Clinical Project Manager will be accountable for the delivery of one or more studies from protocol through to study report and archiving. These can be all types of study from First in Human to Phase 4.

The CPM will be accountable for managing the interface between UCB, Phase 1 Units, Contract Research Organizations (CROs) and other vendors to ensure assigned studies are delivered according to contract specifications, with high quality, on time and on budget.

Additionally, the CPM will lead the internal and Joint Clinical Study team; lead study specific decision-making, develop strategies for increasing study efficiencies and co-ordinate issue detection, resolution and, where necessary, escalation to the Program Delivery Leads.

Who you'll work with

You will work closely with the Clinical Study Team(s) and assess the appropriateness of the risk mitigation plan to ensure that the cause, impact, remedial actions & preventative steps are assessed for any issues identified to avoid recurrence.

Engage with KOLs, investigational sites, patient advocacy groups and work closely with the respective Program Delivery Leads, and other team members and stakeholders as required, to serve as the key internal clinical operations contact whilst keeping the Program Delivery Lead (PDL) updated on all study issues.

What you'll do

• Creates, or contributes, to detailed planning of the study timelines, defining critical path, and enabling seamless, and timely, access to bioanalytical and/or safety data for review meetings and so allowing prompt decision making.
  • Such as for Safety Monitoring/Data Monitoring Committees, planned Interim Analyses, and final data reporting for Results Interpretation Meetings and final Clinical Study Report (CSR).
• Ensure that the scope, and all tasks and responsibilities for a study, are appropriately reflected in all study contracts and amendments.
  • Ensure that scope changes are tracked, appropriately endorsed, and reflected in contract amendments before implementation of activities by the CRO/Phase 1 Unit.
• Demonstrate robust oversight of sponsor delegated activities by regularly reviewing CRO/Phase 1 Unit performance through use of KPIs, metrics and deliverables, with a focus on trial subject safety, data quality, and critical activities that might delay the project or impact budget.
• Closely cooperate with Strategic Clinical Partnering (SCP) and, if applicable, relevant committees/governance bodies and/or Clinical Development Quality Lead (CDQL) regarding the performance and quality of work received from the CROs/Phase 1 Units and other vendors.
• Collaborate with members of Clinical Study Team(s) / Joint Clinical Study teams to develop clinical trial protocols, protocol amendments, and other relevant study documents by providing input and/or approval as defined in SOPs and, if applicable, Strategic Partnership (SP) documents. Ensure that these documents are appropriately updated, e.g. in case new safety information or other change in scope.
• Work with CRO partners to define a study specific monitoring strategy. Review Monitoring Plans, and Monitoring Reports (as appropriate).
• Provide input to aid in the development of the clinical database, and clinical operations focused review of the clinical database specifications during set-up, and support data cleaning and data evaluation meetings and Results Interpretation Meetings (RIMs).
• Support Data cleaning and data evaluation meetings (DEM) and Results Interpretation Meetings (RIMs).

Interested? For this role we're looking for the following education, experience and skills

• At least three years' relevant experience in clinical development including team leadership.
• Experience or capability to manage in-house and/or outsourced regional or global Phase 1, 2 or 3 studies (First in Human to multicenter clinical studies) from study start-up to study report completion.
• Motivation, mentoring and integration of individuals on multi-functional international teams.
• Delivery of scientific/medical presentations and training to both large and small audiences.
• Medical knowledge and research expertise
• Basic principles of data management and statistics

*This position's reasonably anticipated base salary range is $121,000-$160,000 annually. The actual salary offered will take into account internal equity and may also vary depending on the candidate's geographic region, job-related knowledge, skills and experience, among other

If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.

RANDATUCB

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-Reasonable_Accommodation@ucb.com 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.