Pfizer Program Lead in Chennai, India
Data Monitoring and Management (DMM) point of contact for assets at the program level. The primary purpose of the role is to ensure provision of operational leadership and expertise in data monitoring and management with an emphasis on effective partnering. Accountabilities include the design, development, and maintenance of key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, overseeing the application of standards, data review and query management, as well as ensuring quality study data set release and consistency in asset/submission data. The DMM Program Lead works closely with the DMM Head and Therapeutic Area Leads to ensure the DMM team functions as a harmonized unit with consistent, timely and high quality application of process and delivery of DMM responsibilities. This role has additional line management responsibilities supporting development, technical, resourcing and workload prioritization.
Acts as the key scientific and technical data management expert at the asset level; define and drive the data management strategy and standards for the Therapeutic Areas (TA) as well as Risk Based Monitoring (RBM) standards, tools, data provisioning, and reporting
(M04 career tract level only) Builds and oversees a high performing team of Clinical Data Scientists to deliver data monitoring and management expertise to Research/Business Units and other Global Product Development lines in a high quality and timely manner
Serves as a functional driver of Quality Gates and manages Significant Quality Events (SQEs)
Anticipates, oversees and influences change to position efficient, high-quality operational delivery
Develops creative solutions to complex problems within and beyond scope of expertise (e.g. TA, discipline, department)
Assumes accountability and as needed responsibility for all DMM activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, and third party study data due diligence and deliverables
Manages risk appropriately to enable innovative solutions
Establishes strong partnerships with BU/RU, department leadership and other functions to advance asset or indication goals
Ensure work carried out by or on behalf of DMM is in accordance with applicable SOP's and working practices.
Ensures DM work is inspection ready and acts as a key data management contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups within Pfizer.
Helps develop a strong talent base within group of Clinical Data Scientists, preparing for long-term development needs, via mentoring or matrix management
Bachelor's degree required. Degree in scientific field preferred. Master's degree preferred.
Knowledge of vendor processes and best practices in outsourcing. Must be capable of building strong relationships with Partners and other vendors.
At least 15 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency.
Supervisory experience required
Oncology-related experience is highly desirable.
Data Management and clinical trials expertise with a thorough understanding of the processes associated with clinical drug development and data analysis operations required for the reporting of clinical trials and global regulatory submissions.
Thorough understanding of regulatory requirements and relevant data standards. CDISC knowledge and experience are preferable.
Strong communication (written and oral), leadership, decision-making, influencing, negotiation, and project management skills
Sound knowledge and experience working across international boundaries and cultures.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.