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:
o Proactive management of internal partners/stakeholders including Clinical Research, Project Management, CR&D Operations, and Affiliates and foster partnership across the multi-disciplinary teams
o Proactive management of external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers
Functional Scientific/Technical Skills
• Strong study management expertise
• Advanced knowledge of Clinical Trial Process (CTP) and development process
• Advanced project management skills with little assistance over time
• Advanced knowledge of GCP/ICH and local guidelines, regulations and directives
• Excellent oral and written skills and ability to effectively apply these skills
• Advanced computer technical skills
• Develops/manages clinical trial budgets independently
Advanced cross functional awareness
BA / BS
• Degree in relevant discipline
• Minimum 4 years clinical study management experience including multinational experience
Experience in oversight of CRO study execution preferred
• 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
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.