Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The Clinical Trial Manager provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs. They are the primary operational contact for the study and lead the cross-functional global team for execution of the study. Responsibilities may include operational direction of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams. They should have the command of the projects, the ability to zoom in and out as the situation demands and deliver high quality presentations to senior and executive leadership within and outside of Celgene (as appropriate). The Clinical trial manager should have critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines.
Responsibilities involve a combination of execution and oversight—dependent on the sourcing model — to ensure deliverables and may include, but are not limited to, the following:
Financial Planning and Management
Strong understanding of the cost drivers, attuned to principles of cost disciplined science and are able to proactively manage the study budget.
Takes ownership and accountability for the Development/management/reconciliation of overall study budget(s)
Development/management of vendor scope of work (SOW) per contract, quality, and budget
Review/approval of vendor invoices and management of accruals and SOW changes.
Drive study execution utilizing available performance metrics and quality indicators
Oversight of clinical monitoring quality and adherence to established processes and plans
Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders using data and strong inter-personal influencing skills to make robust data driven decisions.
Proactive identification of potential risks and development/implementation of actions to avoid or mitigate and able to make the appropriate trade-offs of balancing risks with study deliverables and costs.
Maintenance/updating of data as appropriate in project management tools including CTMS
Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation
Study Planning and Conduct
Facilitation of country and site feasibility/selection processes with use of robust data
Operational and strategic input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
Oversight of investigational product [IP]supply forecasting/management and study-level IP reconciliation [in collaboration with IMSC] and recommend appropriate trade-off to balance risks and study execution deliverables.
Development of the subject recruitment/retention strategy and related initiatives
Participation in clinical service provider (vendor) selection, specification development, and management/oversight
Oversight of TMF set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance
Development/coordination of study training for study team, investigational sites, and vendors
Oversight of required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC approvals/notifications
Participation in Serious Adverse Event (SAE)reconciliation process
Proactive management of issues and information sharing with key internal/external stakeholders with use of standardized reports and other mechanisms.
Development/maintenance of collaborative relationships with:
-Proactive management of internal partners/stakeholders including Clinical Research, Project Management, CR&D Operations, and Affiliates and foster partnership across the multi-disciplinary teams
Clinical trial project management skills
Financial budgeting and forecasting skills
Leadership / influence management skills
In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
Ability to effectively lead a cross-functional team in a matrix environment
Time management skills – ability to effectively multi-task and prioritize
Proven problem solving and decision making skills
Demonstrated success in using oral and written communication skills to influence, inform, or guide others
Disease / therapeutic knowledge
Solid computer skills – requirement of MS applications including (but not limited to) MS Project, Word, Excel
Study Tools including electronic system skills – CTMS / EDC
BA / BS
Degree in relevant discipline
Minimum 4 years clinical study management experience including multinational experience
Experience in oversight of CRO study
Creates realistic plans that clearly define goals, milestones, responsibilities and results
Maintains focus on strategic objectives while accomplishing operational goals
Places a priority on getting results with an emphasis on high quality outcomes
Holds self and others accountable for accomplishing goals
Makes timely, data-driven decisions
Develops and maintains effective working relationships with people across cultures
Encourages collaboration across teams, functions, and geographies
Ensures that conflict is handled constructively so that performance is not impacted
Displays a willingness to challenge the status quo and take risks
Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute
Maintains optimism and composure in times of change, uncertainty, or stress
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.