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. Your focus and ability to meet team targets will help in completing critical deliverables.

• 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.

• Bachelor's Degree
• 3+ years' experience
• Experience in clinical trial administration
• Demonstrated success/results in prior roles including matrix organization
• Demonstrated knowledge of quality and regulatory requirements across a range of different countries
• 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

• Master's degree
• Relevant therapeutic area experience
• High level of project management skills