- Job Summary:
- R esponsib le for the overall operation, excellence, quality, integrity, compliance, and safety of PCRU clinical coordination activities.
- Leads and manages Clinical Coordinator team.
- Supports strategic direction, leadership, business performance and long term strategy of PCRU clinical trial operations .
- Role may also require providing clinical oversight, subject safety, and regulatory compliance coverage during weekends as necessary.
- Manages clinical coordinators and directs their professional career growth and development.
- E nsure s successful study planning resulting in timely and precise study execution while maintaining data quality and integrity.
- Supports strategic direction and provides technical and functional expertise, guidance and oversight to study execution.
- Demonstrates Pfizer Core Values of Courage, Excellence, Equity and Joy in communication and leadership behaviors
- L eads Clinic al Coordinators in review of draft protocols.
- Accountable for ensuring Clinical Coordinator data quality checks are completed to support study timelines e.g. database lock
- Collaborates with Clinical Services Manager (s) (CSM) in bridging clinical coordination activities and clinical bedside activities to ensure successful execution of study protocols .
- Collaborates with Local Operations Team in prov iding overall decision and input in study planning, timelines, execution, and implementation.
- Represents clinic as SME for various projects , e.g. PIMS upgrades, SOP development, process mapping, and work flow instructions.
- Collaborates with Technical Training Manager to d evelop training curricula and serves as preceptor for newly hired Clinical Coordinators .
- Upholds the tenets of Good Documentation Practice (GDP) and Good Clinical Practice (GCP).
- Act s as CRU ambass ador for visitors internal and external to Pfizer
- Explores, coordinate s, and assures implementation of emerging technologies/techniques as needed per protocol to enhance the PCRU capabilities, efficiency, productivity, competitiveness and data quality.
- Contributes to writing, review, and implementation of CMCDs and operational practices
- Collaborates between PCRUs to promote harmonization and align best practices.
- Challenges existing paradigms in clinical research and encourages novel study designs and research approaches; works to improve study conduct, data capture and retrieval and submission processes
- Acts to achieve departmental and WRD goals
- Minimum of Bachelor of Science degree in Life, Biomedical, or Social science or equivalent prior related work experience required. Bachelor of Science in a health related field preferred.
- Minimum of 5 years of work experience in clinical research trials as a data collector, clinical research technician, study coordinator, or data manager. Prior experience in Phase 1 research advantageous.
- Minimum 1-3 years of work experience coaching or mentoring. People manager experience (including staff development, conflict resolution, allocation of resources, change management) preferred .
- Leadership/Management formal education and/or work specific training (e.g. supervisory skills development; interview and selection).
- Evidence of continuing education/training relative to drug development/study conduct
- Current certification for Basic Life Support (BLS) required
- Current certification for Advanced Cardiac Life Support (ACLS) preferred (New Haven only)
- Excellent command and fluency in English language (verbal and written).
- Good written and verbal skills in French and Dutch (Brussels only)
- Experience in public speaking and delivery of scientific and management educational presentations.
- Excellent working knowledge of computers
- Working knowledge of laboratory data handling acquisition systems
- Proficiency in Microsoft (MS) Office and the ability to learn different software programs.
- Proficiency in Phase I Management Systems (PIMS) Electronic Data Capturing Management System (EDCMS) platform.
Scientific/ Clinical/ Research Knowledge:
- T echnical/functional expert in Phase I Clinical Operations preferred .
- Excellent knowledge of medical conditions, nursing and research techniques, and application of clinical research
- Ability to review and understand emerging safety and efficacy profile of a drug candidate and recognize potential serious adverse effects.
- Ability to align clinical skill sets with protocol requirements to assure appropriate staffing for studies
- Demonstrated understanding of the complexities and recent developments in exploratory research.
- Exhibits quality consciousness with high degree of ethics and integrity carrying out duties in accordance to laws, regulatory standards, and company policies and procedures.
- Reports directly to the Senior Manager Clinical Services Operational Excellence .
- Functional working relationship with Project Managers, Clinical Services Manager s , Technical Training Manager, Principal Investigators, Systems Administrator s , Finances, and clinical services staff.
- Participat es in multifunctional, interdepartmental management teams.
- Clinical coordination point of contact for Pfizer internal departments ( Dev.Ops , CRDC, Clinical Training, BTi , QA, HR,...), external consultants , acts as PCRU ambassador
- Act as contractor Sponsor
Resources Managed Supervision:
- Clinical coordinators
- Contractor sponsor
- Matrix responsibility to entire Clinical Services Department
- Budget estimation and manage performance against budget
- Signature authorization as per ASL
#LI-PFEPfizer 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 Act
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