Why Patients Need YouEverything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.What You Will AchieveAccountable for the training and support of the Brussels PCRU Laboratory Project Coordinators; to include planning and Laboratory protocol adherence and data quality of assigned laboratory projects in the Brussels PCRU in accordance with scientific, medical and ethical principles and with GxP requirement guidelines. Also accountable for training of data cache activities (study QC and reconciliation of issues) at study closeout and may assist in support of electronic notebooks or other digital applications, or data transfer requirements. Works with PCRU study team members or Biomarker Leads to execute clinical trials or external biomarker development that meet regulatory guidelines, project team timelines, and quality requirements. Serves as an expert to troubleshoot laboratory-based issues that arise in the preparation, conduct, close-out of clinical trials. Provides novel approaches to resolving problems and issues that may arise within the Safety or Biomarker Laboratories during assay conduct.How You Will Achieve ItTrain and support Brussels Laboratory Project Coordinators on the following responsibilities:
Supports Brussels Laboratory Project Coordinators to coordinate laboratory projects with all customers (organize laboratory project meetings, ensure clarity of laboratory processes) and organizes laboratory project planning and budget
Reviews Laboratory protocols and provides feasibility assessments on the ability to perform laboratory requirements and procedures
Develops and setup laboratory capabilities and competencies required for conducting laboratory activities in the PCRU BR in due time
Ensures the Laboratory components of clinical trials are conducted according to the protocol requirement, objectives, and timelines
Ensures that the assigned projects are carried out following GxP, scientific, medical, and ethical principles, within regulatory requirements/guidelines, and standard operating procedures
Works closely and communicates with all stakeholders (PCRU colleagues & external vendors) for the management of the day to day study activities for immediate & medium/long term problem solving, ensuring that project milestones are met
Overseeing the collection and documentation of assigned Laboratory study data
Performs ongoing & regular quality reviews of laboratory data for achieving audit-readiness
Maintains quality processes and SOPs related to assigned projects and assists in continuous process improvement in our laboratory
Supports the Laboratory planning and schedule aiming to forecast sufficient trained resources upfront
May support building of Electronic Notebook or other automated digital applications as assigned.
May support data quality checks and data transmission processes as assigned.
QualificationsMust-Have
Minimum of a bachelor's degree in Medical Technology or other Health Science related discipline.
American Society of Clinical Pathology (ASCP) certified.
Minimum of 6 years of relevant work experience in pharmaceutical, hospital, or medical research.
Knowledge of clinical trials.
Working knowledge of GxP, GCP, CAP, and CLIA regulations.
Working knowledge of computers and laboratory data handling acquisition systems and associated issues/risks.
Working knowledge of Word, Excel, Teams, and Database applications
Working knowledge of LIMS systems and electronic notebooks
Nice to Have
Minimum of a bachelor's degree in Medical Technology or other Health Science related discipline with 4+ years of experience.
Understanding and demonstrated proficiency in handling laboratory projects.
Knowledge of a pharmaceutical clinical research unit environment.
Laboratory LIS system utilization.
Basic knowledge of Sequel or similar programs. Ability to write scripts to resolve issues.
Ability to challenge existing paradigms in clinical research and to encourage novel designs/ideas and research approaches to improve study conduct, data capture, retrieval and submission processes.
Demonstrates team work by effective participation in multifunctional teams, motivate colleagues, build relationships with customers, and finding opportunities for collaboration.
PHYSICAL/MENTAL REQUIREMENTSNANON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Early morning hours to collaborate with Brussels colleagues.
Other Job Details:
Last Date to Apply for Job: 31 MAY 2024
Eligible for Employee Referral Bonus
NOT Eligible for Relocation Assistance
Work Location Assignment:On PremiseOn Premise colleagues work in a Pfizer site because it's needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-siteThe annual base salary for this position ranges from $74,900.00 to $124,800.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.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. This position requires permanent work authorization in the United States.Research and Development