Pfizer Clinical Research Scientist and Operations Lead in Collegeville, Pennsylvania

About Pfizer

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description

The Clinical Research Scientist and Operations Lead (CRSOL) will provide scientific and operational support for multiple global Phase 4 clinical and epidemiologic studies across all vaccine programs within Medical Development, Scientific and Clinical Affairs (MDSCA). Studies may include routine clinical trials, Research Collaborations and non-interventional studies globally. This individual will be responsible for working collaboratively with the Clinical Scientists, Clinical Lead, Medical and Scientific Affairs physicians, to develop study strategies in support of the various vaccine clinical plans. The CRSOL may be responsible for drafting study protocols, informed consents, training materials, and other critical study documents. This individual will also be responsible for leading the operational aspects of the research projects assigned, to ensure high quality management and implementation of clinical research collaborations and other Pfizer-sponsored research initiatives. They will be responsible for coordinating activities and deliverables for all assigned projects within the Clinical Affairs group. They will liase with members of the extended MDSCA team, as well as with other Pfizer partners including, but not limited to, Development Operations, Regulatory Affairs, Safety & Risk Management, Business Process Owners, Clinical Research Collaboration Liaison, Protocol Operations Lead, Outsourcing & Contracting, Accounts Payable, etc. The individual may also provide project support for cross-functional teams including program Epidemiology Subteams.

Responsibilities

  1. PROTOCOL AND STUDY DESIGNWrite/design protocol outlines, protocols, and amendments of moderate complexity in collaboration with the CS Lead, Medical Monitor, Statisticians, and other relevant study team membersLead study design and strategy discussions of moderate complexity Create informed consent form templates, and review site prepared informed consentsSupport the preparation of other clinical documents as required Create medical training materials for sitesConduct specific medical/protocol/safety training at investigator meetings, kick-off meetings, etc., as neededComplete clinical and other relevant operational sections of the Site Reference Manuals, as needed, for the various study types conducted in MDSCAProvide input on country and site feasibility activities 2. STUDY IMPLEMENTATION Manage operational aspects of epidemiologic and non-interventional projects run by MDSCA *Facilitate and coordinate the selection of the appropriate study implementation pathway (i.e. SOP selection)Prepare required study documents including, but not limited to, concept submission, due diligence checklist, laboratory worksheets, supply requests, etc. Oversee and act as primary contact for vendors, including laboratory and/or clinical research organizationsLiaise with external vendors to ensure laboratory supplies and sample shipment arrangements are made in accordance with protocol requirementsPrepare study/project timelines and track progress against stated milestones and deliverablesTrack Pfizer SOP process steps from concept development through study close-outEnsure appropriate documentation is generated and filed for protocol review and approval through the MDSCA review processesLiaise with external collaborators, key opinion leaders, to obtain relevant required documentation need in support of various research activities Establish and maintain study contact listsManage financial aspects of research projects including, but not limited to, tracking invoicing and payment activities, and alignment with departmental budget forecasts Assist with filing study documents in the appropriate Pfizer repository (i.e. GDMS, INSPIRE, PTMF)3. DATA REVIEW / STUDY OVERSIGHTLead and/or assist in the development of data collection tools and database set-up, applying Pfizer standards as appropriatePerform data review, as appropriate, to identify issues of moderate complexityFacilitate team review and discussion of analyses and reports provided by external collaboratorsProvide guidance and feedback to sites regarding protocol implementationParticipate in any internal or external audits that may occur on an assigned projectEnsure compliance with Pfizer SOPs as well as external regulatory requirements is maintained at the study levelEnsure compliance with safety reporting requirements for Pfizer-sponsored non-interventional studiesReview vendor/collaborator monitoring plans, study quality plans, data review plans, and other relevant oversight documents to ensure data integrity and compliance4. DEPARTMENT LEVEL SUPPORTResponsible for management and maintenance of the master study tracker for MDSCA to ensure accurate and current information is availableContribute to program and project improvement initiatives to drive efficiency and consistency across programsPerform regular and ad hoc updates to the budget tracking system (i.e. Tactical Matrix) to ensure budget forecasting data for MDSCA clinical projects are current and accurate Reconcile data contained in the master study tracker and the Tactical Matrix for completeness and accuracyGenerate extracts and/or reports, as needed, from either system to facilitate reporting and information sharing within and external to MDSCALiaise with Business Technology partner to improve functionality and usability of the master study tracker as needed5. EPIDEMIOLOGY SUPPORTIn collaboration with the Lead Clinician and/or Medical Lead for a given program, and as needed:Prepare and present study concepts and/or protocols to Epidemiology Subteams for assigned projectsAssist in coordinating the review and finalization of the outlines/protocols evaluated at the program Epidemiology SubteamsAssist in preparation of presentations

Qualifications

BA/BS Degree in science, health-related field or epidemiology, or equivalent relevant experience is requiredPrior clinical trial, non-interventional study and/or epidemiologic study experience is required; minimum 5-7 years is preferredExperience with participating in and supporting a multidisciplinary teamExperience in project management Strong ability to organize tasks, time and priorities of self and others; ability to multi-task to support various projects across a number of vaccine programs *Ability to work independently with minimal supervisionExceptional written and oral communication and cross-functional collaborative skills*Proficiency in MS Word, Excel, and PowerpointNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS *Some travel may be required, on an as-needed basis, to support projects globally. *Occasional work will be required after normal business hours to accommodate projects in other time zones.

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.

Clinical Research Scientist and Operations Lead Collegeville, Pennsylvania 1042651