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 a Senior Associate, your
knowledge and skills will contribute towards the goals and objectives of the
team.02 Your focus and ability to meet team targets will help in completing
critical deliverables.
It is your hard work and commitment that will help in making Pfizer ready to
achieve new milestones and help patients across the globe.
How You Will Achieve It
* Contribute to the completion of complex projects, manage own time to meet
agreed targets and develop plans for work activities on own projects within a
team.
* Identify issues that may impact on the conduct of the study and ensure
appropriate closure of all issues.
* Assist Clinical Research Site Assistant in site activation activities such
as gathering IIP documentation where required to ensure timely site activation.
* Reviews data to ensure quality and completeness, including Quality Control
(QC) review of documents.
* Ensure clinical trials data are submitted to data management in a timely
fashion.
* Support the study clinician in ensuring patient safety and eligibility.
* Ensure induction and appropriate Pfizer specific trainings are undertaken.
* Provide support for coordinating with sites for finalizing budget
worksheets and contractual agreements.
* Maintain accurate site-level information on corporate clinical trials
registry.
* Support study team as needed with Regulatory, Central, and Local Ethics
Submissions and responses.
* Ensure patient safety is maintained and all safety issues are reported
correctly according to all relevant local and international regulatory
requirements.
* Maintenance of Electronic Library and Records Archive etc. to ensure audit
trail is complete and accurate.
* Attend investigator meeting when required.
Qualifications
Must-Have
* Bachelor's Degree
* 0-1 years' experience
* Demonstrated success/results in prior roles in projects
* Knowledge of International Conference on Harmonization Good Clinical
Practices and local regulations
* Knowledge of applications used in the clinical trials
* SOP compliance knowledge and expertise on all relevant SOPs
* Effective verbal and written communication skills, and must be fluent in
English
* Proficiency in Microsoft SharePoint, SharePoint Designer etc
Nice-to-Have
* Master's degree
* Relevant therapeutic area experience
* High level of project management skills
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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