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Clinical Coordinator Manager

Employer
Pfizer
Location
New Haven, Connecticut
Salary
Competitive
Closing date
Oct 9, 2022

View more

Discipline
Health Sciences, Medicine
Position Type
Full Time
Job Type
Manager, Other
Organization Type
Pharma
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  • 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.


    Job Responsibilities:
    • 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


    Basic Qualifications/Skills:
    • 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)


    Communication:
    • 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.


    IT Knowledge:
    • 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.


    Organizational Relationships:
    • 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


    Financial Accountability:
    • Budget estimation and manage performance against budget
    • Signature authorization as per ASL


#LI-PFE

Relocation assistance may be available based on business needs and/or eligibility.

Pfizer 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

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.

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