- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
2. If applicable, accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
3. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
4. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
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5. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Qualifications
Must-Have
- 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
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