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Why Patients Need You
Pfizer Worldwide Medical and Safety colleagues play a key role in connecting
evidenced based, medical decision support with colleagues and stakeholders to
enable better health and treatment outcomes. Whether you are creating framework
necessary to ensure our evidence is scientifically sound, providing unbiased,
medically necessary expertise or investigating how to close gaps in data, our
mission is simple. Empower healthcare decisions regarding the safe and
appropriate use of medicines for patients.
What You Will Achieve
You will facilitate in conducting clinical trials and monitoring their
progress. You will coordinate all activities that support the clinical trials
and assist the managers in conducting them. As an associate, your focus on the
job will contribute in achieving project tasks and goals.
It is your hard work and focus that will help in making Pfizer ready to
achieve new milestones and help patients across the globe.
How You Will Achieve It
* Contribute to completion of project milestones and organize own work to
meet project task deadlines.
* Maintain Pfizer Trial Master File (PTMF) in accordance with International
Council for Harmonization - Good Clinical Practice (ICH-GCP) and Standard
Operating Procedures (SOPs).
* Review shared space to ensure others are updating tracking and files as
requested by the team.
* Update the trial and site information as necessary in Corporate Clinical
Trial Registry in a timely manner.
* Support and coordinate the Clinical Trial Application to ethics committee
and regulatory authority, if applicable, to obtain approval within required
timeline.
* Provide protocol and Informed Consent Document (ICD) Administrative Support
to global Project Managers and Study Managers.
* Support and coordinate any activities as requested by PMs/SMs and as
assigned within required timelines.
* Maintain / develop local tracking spreadsheets for study-related documents,
data, activities and prepare site supportive material.
* Attend appropriate training programs and project teleconferences as
applicable.
* Assist team with the preparation of any documents or tracking and updating
information.
* Identify and implement process improvements for inspection readiness,
Pfizer Trial Master File (PTMF) compliance, Investigator Meeting organization.
* Ensure the reconciliation of Trial Master File and the Site Master File on
a periodic basis.
Qualifications
Must-Have
* Bachelor's Degree
* Relevant work experience in a health related discipline, pharmaceutical or
medical research
* Demonstrated ability to introduce new ideas
* Knowledge on all relevant Standard Operating Procedures
* Ability to prioritize multiple tasks and develop strategies for completion
of all required activities
* Ability to build collaborative working relationships with colleagues and
associates both within and external to the organization
Nice-to-Have
* Experience in management of clinical trial and/or regulatory documents
* Knowledge of International Conference on Harmonization Good Clinical
Practices and local regulations
* Knowledge of application used in the clinical trials0202
Work Location Assignment:02On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.
Medical
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