Director, Clinical Systems Management
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 position is responsible for delivery of the strategy and operational processes required by regulations for modules within a clinical trial planning and management platform. Key responsibilities include, but are not limited to, (1) Management of the platform to ensure processes and documents address user needs, meet regulatory requirements and are implemented/managed appropriately, (2) Management of stakeholders to ensure business needs are met and communications are clear and timely, (3) Overseeing change requests and issue and performance management processes and leading assessment of trends that may require a process or system update, (4) Monitor business needs and work with vendor to identify capabilities or changes needed to meet the needs.
• Platform Management
- Oversee development/primary owner of processes and system documentation and ensure key stakeholders are involved in the review, implementation and management of processes and documents. This includes, but is not limited to, SOPs, WPs, Forms, Tools/User Guides, Training Materials and Validation documents.
- Oversee/assess impact of proposed integrations or other types of changes Identify, facilitate and help drive decision making for system upgrades. Assess business impact (with functional representatives) and drive implementation
- Ensure coordinated tracking of enhancements and defects
- Align with vendor on new releases
- Prioritize and drive capability requirements
- Partner with vendors and internal IT for Roadmap management
- Identify needs and resources for significant upgrades
- Monitor all processes to ensure being followed
• Stakeholder Management
- Lead development of business case(s) for new capabilities/modules working with internal and external stakeholders and functional business leads/SMEs
- Drive training and communications across internal and external stakeholders
- Actively engage with clinical systems governance committee and lead/facilitate cross-functional platform discussions
- Coordinate with functional leads to manage external stakeholder (e.g. CRO) impact through development and implementation of a communication and change management plan
• Contract and Financial Management
- Manage and oversee vendor contracts in collaboration with IT and Procurement
- Manage relationship with system vendor
- Review and approve vendor invoices
• Performance/Use Management
- Track Platform usage
- Oversee, manage and report process and value realization metrics
- Analyze trends
• Audit and Compliance Management
- Manage audit / inspection touch points
- Ensure compliance / usage of operational terms and definitions, business rules as defined by associated governance bodies
•10+ years of experience developing requirements for and supporting global systems used for clinical trial operations. This includes but is limited to clinical trial management, risk based monitoring, electronic data capture, electronic documentation management/filing, grants planning and site financial management.
• Requires direct experience implementing processes for systems in production that meet requirements outlined in 21 CFR part 11, FDA, WHO and EMEA guidelines related to clinical systems.
Skills/Knowledge Required: •Excellent people interaction skills, adaptability, strong professional diplomacy and positive business approach •Excellent problem solving ability and analytical approach, with a focus on strategy development and execution, with strong ability to manage and re-prioritize competing responsibilities independently •Demonstrated ability to drive execution and innovation in a dynamic environment •Self-motivated with exceptional follow-through •Experience in successfully implementing new business capabilities and technology solutions •Excellent written, verbal and interpersonal communication skills •Proficient with risk and issue management and resolution; fosters calculated risk taking •Proficient with business process, operations and metric definition best practices •Familiarity with clinical system regulations/requirements
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.