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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.
Under the direction and in collaboration with the Project Manager, provides operational expertise and leadership to manage and support clinical operations teams, ensuring maintenance of quality, timelines and budget in the delivery on the operational aspects of one or more clinical trials through all periods of conduct (planning, initiation, conduct, closure), in accordance with the appropriate quality standards including ICH/GCP, Receptos SOPs, and applicable regulations, rules and guidance.
Main Responsibilities and Accountabilities:
- Provides operational support, direction and leadership to one or more clinical operations teams and/or subteams.
- Manages and supports activities related to the development and execution of cross-functional and third-party vendor activities and deliverables, including but not limited to, development and/or review of clinical data management conduct (e.g. CRFs, CRF guidelines, edit check specifications, database cleaning), relevant study plans (e.g., monitoring, quality, communication, etc.) protocol review for operational feasibility and consistency, tracking patient recruitment, and incentives.
- Participate in the development and management of the study timelines.
- Maintains oversight of and ensures consistency in the operational aspects of trial conduct and provides training across trials within a project, including involvement in daily management of CRO/Vendors/Contractors.
- Performs routine reviews of key data to identify trends, discrepancies, errors, etc. to ensure ongoing quality of conduct in accordance with the clinical development plan and applicable clinical trial protocol.
- Performs in-house review of site visit reports and tracking to ensure appropriate monitoring of trial conduct and satisfactory resolution of outstanding issues.
- Ensures consistency and quality of site monitoring visits, which may include conduct of periodic co-monitoring visits with CRAs and/or training and supervision of co-monitors.
- Ensures communication of relevant study information across study personnel, timely communication of urgent information to the appropriate Team members, and appropriate escalation of issues to study team leadership.
- Collaborates with other study Team members to ensure consistency and efficiencies across the study Team, and other in-house teams as assigned.
- Participates in maintaining tracking, management and reporting of clinical study budgets and in development of staffing/resourcing plans.
- Maintains and provides contemporaneous enrollment projections to support forecasting and management of clinical trial material and investigational product.
- Oversees the development and maintenance of study specific manuals and plans.
- Identifies and develops metrics and operational tracking tools to support the operations team and for reporting to senior management on clinical trial conduct.
- Develops, maintains and promotes positive, effective and collaborative working relationships with and among internal team members and as applicable, with external CRO and 3rd party vendor personnel and co-development partner study teams.
- Identifies areas of best practice and process improvements.
- Participates as requested in the development of SOPs and department level training.
- Participates in Clinical Operations initiatives and programs as assigned, including but not limited to development of SOPs, cross project initiatives, training, etc.
- Maintains awareness and training on current applicable regulations, rules, guidance and Receptos SOPs/Work Instructions.
- Ensures clinical trials are conducted in compliance with ICH/GCP, applicable regulations, rules and guidance, and applicable SOPs and Work Instructions.
- Other responsibilities as assigned.
- Experience in supporting a Project Manager/Director leading a team or subteam in the operational aspects of managing phase 1-4 clinical studies/trials through all periods (initiation to closeout), collaborating with and managing vendors and/or CROs, and planning cross-functional operational activities within an organization, preferably working in a global environment.
- Basic knowledge of project management related to operational aspects of a clinical study/trial including some experience supporting a Project Manager in the development of timelines, budgets and resource plans.
- Good knowledge of ICH GCP and US Code of Federal Regulations applicable to the conduct of clinical trials (i.e., 21 CFR Parts 11, 50, 54, 56, 312 and 314).
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
- Experience leading a small study or functional subteams with demonstrated ability to motivate and lead the team to deliver against commitments.
- Well-developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.
- Able to travel up to 25% including international travel.
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.