The Standards Operations Program Manager is accountable for the oversight and coordination of technical standards requests in support of study start-up and maintenance activities within the Clinical Database Services (CDS) or Reporting and Mapping (RaM) functional areas. In that capacity, they oversee the day-to-day project assignments of Technical Architects ensuring adherence to clinical database standards, standard operating procedures (SOPs) and other applicable guidelines.
- Coordinates with functional and cross-functional resources to ensure standards request priorities are aligned and functional activities are appropriately resourced and executed on time and with quality.
- Attends and actively contributes to standards governance, portfolio management, and other meeting forums as necessary. Serves as a central point of contact for the functional area related to technical standards request operations. May engage with other functional areas within GCDI to ensure awareness and alignment of process, resources, and deliverables.
- Interacts with staff across our Company's multiple sites and geographies.
- Mentors, guides, and provides leadership. May initiate, lead, and/or participate in departmental process improvement initiatives as assigned.
- Understands the strategy for library level standards (from requirements gathering through technical implementation) ensuring technical standards requests are executed on time and with quality. Jointly with functional SMEs, participates, contributes, and leads (where appropriate) technical discussions in Standards Governance forums.
- Works independently with different functional groups to ensure appropriate resourcing and coordinates execution of standards level deliverables.
- Partners with functional area representatives to assess and promote program-level consistency in the use of database standards and program-level design.
- Provides program-related oversight and guidance to the Technical Architects and promotes quality and consistency in the use of database standards and deliverables across trials within a program.
- Keeps abreast of project management, technology and clinical data management disciplines through interaction with experts both within and outside of our Company. Identifies and develops improvements to data collection and data management processes and tools.
- Supports audits and inspections as necessary. May provide training and education for stakeholders. May develop, or assist in development of, reference and/or training material. May provide cross-functional internal and external communication as needed. Obtains internal and external stakeholder feedback on a regular basis; this may include meeting with subject matter experts or representatives from stakeholder functional areas.
- Contributes to training development for Technical Architects, including updates to the FAQs and appropriate partnering for staff as needed. Coordinates COE Meetings for the Technical Architect team to ensure appropriate knowledge sharing and problem-solving effort for consistent messaging.
- Uses excellent social, negotiating, and project management skills to perform the following tasks: Project plan development, execution, and change control Team facilitation and resource coordination Risk management Stakeholder management and communication including status reporting.
B.A. or B.S., preferably computer science, or related discipline. Minimum of 8-10 years in software development life-cycle with programming skills and/or project management skills. At least 6 years’ in Clinical Data Management (or related discipline) in technology solution implementation. Minimum of 6 years’ in data management, medical research, or database design and development. Has managed data collection/flow standards and supporting studies through the full data management life-cycle. At least 3 years’ working with formal project management tools and processes.
Knowledge and Skills:
In-depth knowledge of the clinical development process; thorough knowledge of clinical data management; demonstrated knowledge of technical processes inclusive of electronic Case Report Form (eCRF) development, clinical database development, data validation tool development, user acceptance testing, data integration from different sources, data flow/migration, and application of CDASH and SDTM standards.
Have highly effective communications skills and relationship/stakeholder management skills. Demonstrated leadership and project management skills. Strong organization, negotiation, and problem-solving skills. Strong customer-focus and interacts effectively with different functional groups. Assessing needs and translating to resourcing requirements, essential. Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.