Pfizer
Website:
pfizer.com
Company:
https://www.linkedin.com/company/pfizer
Seniority: Mid-Senior level
Industries: Pharmaceutical Manufacturing
Job details:
Use Your Power for Purpose
At Pfizer, our mission is to empower healthcare decisions regarding the safe and appropriate use of medicines for patients. You will play a pivotal role in improving patients' lives by ensuring the accuracy, timeliness, and consistency of clinical data. Your work will bridge evidence-based medical decision support with colleagues and stakeholders, enhancing health and treatment outcomes. By developing robust frameworks, providing unbiased expertise, and addressing data gaps, you will contribute to better health outcomes and the safe use of medicines. Your dedication will help Pfizer achieve new milestones and support patients worldwide.
Role Summary
As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Manager, Project Manager, Clinical Database Management is responsible for the provision of project management leadership and expertise in Clinical Data Sciences with an emphasis on clinical databases and related technologies supporting assigned segments of the Pfizer portfolio. Accountabilities include project management and leadership of the design, development, and maintenance of clinical databases and other technical deliverables within Clinical Data Sciences. Oversees the development cycle/change control of database build to ensure the integrity of clinical data and the application of Pfizer standards supporting consistency in asset/submission data. Serves as a Subject Matter Expert for database build in the assigned Therapy Area. The Project Manager, Clinical Database Management works closely with the Clinical Data Scientist to ensure consistent, timely and high quality application of process and delivery of CDS responsibilities. The Project Manager, Clinical Database Management will be accountable to assure process, technologies, and standards are leveraged in a consistent way across assigned projects. May mentor junior staff members
Role Responsibilities
- Works closely with department roles, assigned mentor, and cross-functional study team members to manage the development cycle of data capture solutions that support the quality and timely delivery of data required per standard and study specific data review plans.
- Solves moderately complex problems related to database build and implementation
- May aid with solving problems outside of own department
- Oversees operational activities/projects of professional Work Teams to support short-term Department goals.
- Leads internal initiatives, working with other roles within CDS to improve processes. Represents Database Management on CDS initiatives.
- Complies with applicable SOPs and work practices
- Serve as a project management resource to the study teams for developing and implementing database development project plans.
- Ensure proper planning of study activities in DBM and proactively alert risk and plan mitigation.
- Independently, perform Impact analysis for proposed solutions to existing tools and processes and convey the same to technical and non-technical stakeholders.
- Act as an Expert in the area, applying best practices according to documented processes
- Participate in Pfizer Standards meetings as appropriate
- Ensure compliance always
- Ensure seamless functioning and collaboration of CDS activities between the DBM and Clinical Data Scientist functions.
- Ensure operational excellence in collaboration with partners and colleagues for application of standards within data capture methods in support of the data review plan, in collaboration with the Clinical Data Scientist, ensure operational excellence across all CDS deliverables
- Assess impacts of Change Control and develop mitigation plans for emerging risks and issues.
- Identifies existing process/product improvements
- Develops innovative, advanced new concepts that improve processes / products across own and related disciplines
- Takes appropriate risks to achieve desired result
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Medical
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