Associate Director, Group Lead, Central Testing, Central Services, DMM
Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.What You Will Achieve
It is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility. You will play an important role in processing, reviewing and receiving clinical data and records and from therapeutic groups as well as internal and outside investigators. You will ensure that accurate, timely, and consistent data reaches the clinical teams and other groups. You will be relied on for data management plans, including data preparation and validation activities, among others.
As a Senior Manager, you will be setting the objectives for multiple projects in your division. Your managerial and technical skills will help in guiding the people in your division. Your understanding of the external marketplace and customer requirements will facilitate in instituting knowledge sharing practices in your team and outside. You shall be relied on to manage operational activities that support the goals of the division and sets direction for its success.
It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It
- Set objectives for and manage multiple projects within a division.
- Develop a talent base and anticipates development needs within the area of responsibility.
- Identify existing process and product improvements.
- Work closely with department roles and cross-functional study team members to create data capture solutions that support the quality and timely delivery of data required as per standard and study specific data review plans.
- Understand the drug development process and data operations required for the reporting of clinical trial data.
As part of the Data Monitoring and Management (DMM) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Associate Director, Group Lead, Central Testing (GL-CT) within Central Services will provide technical guidance and ensure timely completion of assigned task. The Group Lead will also work closely with the DMM Clinical Data Sciences, Clinical Database Management and Central Services groups, ensuring a harmonized unit with consistent, timely and high quality application of process and delivery of DMM responsibilities. The role has mentoring responsibilities supporting development, system/technical processes, resources and accountable for the timely and high quality deliverables supporting the Pfizer portfolio.
- Works closely with functions within DMM, Clinical Data Scientist, Database Build Management, Reporting and cross-functional study team members to create, plan and provide solutions that support the quality and timely delivery of data.
- Act as Process Owner for testing processes
- Ensures that any needed documentation for testing is available and/or created throughout the lifespan of the study and or asset for all Central Testing Central Services deliverables and ensures proper filing in the Trial Master File filings as appropriate.
- Understand the Protocol and provide input to Study Team on Database Design, Edit Check Specification and report as appropriate
- Ensures issues are logged in User Acceptance Testing tracker and feedback is provided to Study Team in timely manner.
- Participate in relevant study feedback meetings
- Organize team meetings across geographic regions
- Perform impact analysis based on the findings identified
- Track the lessons learned and share the knowledge across the team
- Complete all the documentation related to study and share it with Study Team
- Escalate issues appropriately
- Complies with applicable SOPs and work practices
- Serve as a Testing resource to the study teams
- Ensure operational excellence in collaboration with partners
- Develops innovative, advanced new concepts that improve processes products across own and related disciplines
- Takes appropriate risks to achieve desired results
- Recognizes development needs and identifies/creates development opportunities within team
- Develops and mentors a talent base and anticipates development needs within the area of responsibility
- Bachelor’s degree required. Degree in scientific field preferred.
- At least 10 years Software development, Lifecycle testing experience required along with experience performing User Acceptance Testing in clinical data management function.
- Working knowledge of clinical development process, understanding concepts of clinical studies and principles of study design.
- Previous experience within database management roles, understanding key processes and principles associated with CRF design, database build (including edit checks, validation and outputs), acquisition/processing of electronic data; data extraction, listing and reporting.
- Knowledge of clinical trial database and its applications.
- Knowledge of Windows Environment and its applications (Outlook, Word, Excel, PowerPoint, Project, etc).
- Experience managing a testing team
- Expert knowledge of testing processes
- Preference provided to those with strong testing background and strong process knowledge
- Master's degree
- CDISC (Clinical Data Interchange Standards Consortium) knowledge and experience
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer 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. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Medical#LI-PFE