The primary purposes of this position are to provide logistical support to clinical study teams for Vaccine Research and Development (VRD) phase I - IV in specimen collection and processing, sample management, and test data management. This includes providing training support to the study managers and clinical operations study team leads, facilitating electronic transfer of data from labs, communication with study managers and resolution of study manager's own time to meet objectives. Will also forecast and plan resource requirements (people, financial and technology) for projects within VRD.ROLE RESPONSIBILITIES
- Manages and leads people and technological aspects within the Sample Management (SM) team as part of VRD.
- Actively shares knowledge with others within SM through existing knowledge sharing processes/systems
- SME on clinical trial sample collection and provides training to clinical sites. Interface with the study managers to resolve shipping schedule issues and edit schedule as necessary. Assist study managers with completing courier questionnaire and provide guidance to study managers on regional sample management requirements. Facilitate resolution of sample shipping issues including shipping supplies, couriers, customs, and permits.
- Maintain and customize the study site training materials for each study and amendment, including training slides and detailed information contained in the site Study Reference Manual.
- Provide support for questions and resolve issues from global study teams on the sample management process, including the process for sample collection, sample processing, storage, shipping, and logistics. Attend all study team meetings on an ongoing basis to maintain awareness of any issues in the individual studies that may affect sample management and to address the issues proactively with the study teams.
- Interface between clinical operations program lead/clinical operations study team leads, study management/data management across programs and Vaccine Research High Throughput Clinical Testing (VR-HCID) to ensure clear communication and issue resolution regarding sample data as well as immunogenicity testing data.
- Work with clinical sites/partners to resolve sample/shipment discrepancies
- Identifies existing process/product improvements and may take appropriate risks to develop innovative ideas/processes/ products and advance new concepts that improve the department's work processes/products.
- Recognizes others' need for development and collaborates with individuals to create a development plan
- Manages the performance of direct reports through goal setting, ongoing assessment and coaching
- Guides direct reports on relevant experiences to meet career objectives
- BS in a scientific discipline with 8 years of lab experience, assay experience and project management experience OR
- MS/MBA in a scientific discipline with 6 years of lab experience, assay experience and project management experience.
- Previous supervisory experience is required.
- Excellent written and oral communication skills
- Training experience
- Excellent analytical abilities and problem solving skills
- Ability to provide leadership, set priorities and be accountable to timeline
Work primarily performed at individual's desk, computer workshop, or may require walking around to various laboratoriesNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Other Job Details
- This position may require occasional weekend and evening work to meet critical business timelines.
- This position may require occasional travel to scientific meetings and other business-related travel.
Eligible for Relocation Package Sunshine Act
Pfizer 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 Eligibility
Pfizer 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.
Research and Development