Recruitment Data Policies Lead Clinical Project Manager

UCB • Raleigh, NC

1d • Hybrid

About The Position

The Lead Project Manager will be accountable for the delivery of patient-centric studies from protocol design through to study report and archiving. These can be all types of study from First in Human to Phase IV, across all geographies and in all UCB therapeutic areas including Gene Therapy. Lead CPMs will be accountable for complex studies across geographies in therapeutic areas/assets that are considered as priority for UCB and/or multiple studies running in parallel. They will also be accountable for the effective interface and influential stakeholder management between UCB, Phase 1 Units, Clinical Research Organizations (CROs) and other vendors to ensure assigned studies are delivered according to contract specifications, with high quality, meeting all major milestones and to budget.

Requirements

• Bachelor’s Degree
• 10 years’ relevant experience in clinical development including team leadership.
• Experience or capability to manage in-house and/or outsourced regional or global Phase 3 studies (First in Human to multicentre clinical studies) from study start-up to study report completion

Nice To Haves

• Substantial experience in study management in different indications and proven ability to manage complex multinational studies or multiple simultaneous studies from start to end.
• Proven record of high impact on study delivery in high visible, high complex challenging global studies.
• Expertise in managing studies, providing guidance, troubleshooting and answering questions related to their area of expertise.
• Demonstrate initiative and adaptability to special problem situations, and challenges.

Responsibilities

• Accountable for the leadership and delivery of all assigned UCB sponsored clinical trials through effective internal and external team stakeholder management in a matrix organisation.
• Responsible for operational updates, issue/mitgations, ensuring open, transparent communication with team members, line management and Clinical Strategic Partnering, escalating within and outside the team as needed.
• Demonstrate robust oversight of sponsor-delegated activities by regularly reviewing CRO/Phase 1 Unit performance, including TMF status, through use of KPIs, metrics and deliverables (such as SQV, Impact), with a focus on trial subject safety, data quality, and critical activities that might delay the project or impact budget.
• Responsible for Site Engagement strategies to support study recruitment at sites.
• Become familiar with the competitive landscapes; engage with Key Opinion Leaders (KOLs), investigational sites, patient advocacy groups and other relevant organizations.
• For assigned studies, be the key internal clinical operations contact, working closely with the respective PDL and other team members.
• In certain scenarios, the Lead CPM may act as the PDL if, for example, there is only one study on a program or for a NIS primary data capture study.
• During start-up, articulate study scope, goals, and expectations of UCB to the CRO/Phase 1 Unit and ensure all relevant information that may impact the set-up of the trial is highlighted and accounted for in the study planning.
• Responsible for detailed planning of study timelines to enable timely access and prompt decision making for all data for Safety Monitoring/Data Monitoring Committees, planned Interim Analyses, final data reporting for Results Interpretation Meetings and final Clinical Study Report (CSR).
• Responsible to manage, track and ensure accuracy of study budgets in UCB systems, including the forecast and accrual information.
• Work with CRO partners to define a study specific monitoring strategy.
• Review Monitoring Plans, and CRA generated reports (as appropriate).
• Support any audit/inspection activities, including audit/inspection readiness, ensuring findings are appropriately addressed in a timely manner and overall compliance with regulations (eg, ICH GCP) and applicable quality standards at all times.
• Identify issues/gaps in processes and interfaces with other groups and departments and develop recommendations for resolution.
• Contribute to process improvement initiatives, and share best practice experiences with line manager, peers and Partner CROs.
• Mentor CPM/Senior CPMs in operational aspects of study conduct, as needed.

Benefits

• We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work.
• A place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior