The Program Manager –Standards Operations Manager is responsible for oversight and coordination of the standards requests that affect study start up activities for the tower (CDS/RaM). This includes oversight of the Technical Architect, their work assignments, training, and communications. In this role, participate, contribute and lead technical discussions/issues in the forums (SISPM/SRCTT and other forums). In addition, the Program Manager is an active participant in the Standards Governance activities across the portfolio ensuring adherence to clinical database standards, standard operating procedures (SOPs), and other applicable guidelines. Coordinates with the standards manager(s) to ensure Standards Request priorities are met and ensuring all aspects of the activities are resourced and executed on time and with appropriate quality. Acts as the single point of contact for the tower and represents Global Data Management on cross-functional program teams and in other program-level development forums. Engages with the functional areas to ensure awareness and alignment across technical processes and deliverables of Standards Request(s)/delivery at Program level. Contributes to departmental strategies and develops innovative solutions to simplify, standardize, and enhance processes to improve the productivity of the organization. May initiate, lead, and/or participate in process and technology improvement initiatives and industry forums involving the acquisition, management, analysis, and reporting of external data. Interacts with staff across multiple sites and vendors. Mentors, guides, and provides leadership to the teams as assigned.
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
- Oversees the strategy for library level standards (from protocol development through system closeout) ensuring they are executed on time and with high standard quality. Serves as the GCDI representatives for Standards Governance (e.g., SISPM, SRC TT). Together with functional SMEs, participates, contributes and leads technical discussions in these Governance forums.
- Works independently with different functional groups to ensure appropriate resourcing and coordinate 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.
- Uses excellent interpersonal, 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
- Keeps abreast of project management, technology and clinical data management disciplines through interaction with experts both within and outside of the company.
- Identifies and develops improvements to data collection and data management processes and tools. Supports audits and inspections as necessary.
- May provide support for successful integration of our company's and vendor systems. Responsibilities may include managing requirement specifications, issue resolution, development of enhancements, and process changes.
- 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.
- Ensures appropriate training for the 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.
B.A. or B.S. degree, preferably computer science, or related discipline.
- Minimum of 8-10 years of experience in software development life-cycle with programming skills and project management skills.
- At least 6 years’ experience in Clinical Data Management (or related discipline) for technology acquisition and implementation.
- Minimum of 6 years’ experience in data management, medical research, or database design and development.
- Experience managing data collection/flow standards and supporting studies through the full data management life-cycle is required.
- At least 3 years’ experience 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.
- Must 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.
- Experience in 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.