QUALIFICATIONS AND JOB DESCRIPTION

At Pfizer, we are working to “deliver breakthroughs that change patients’ lives”!

As active supporters of diversity and inclusion, we work to achieve our mission with our values of “Courage, Excellence, Equity, and Joy”. We declare, “There are no limits here when it comes to touching lives”, and we believe that “science will win”. In the Pfizer world we fell “the joy of working for life,” have a career path” full of opportunities,” and enjoy a “flexible and pleasant working environment.”

We look forward to having you join us to challenge the status quo with breakthroughs, to change patients’ lives by always doing the best, to always do the right thing, to act responsibly towards each other and patients, and to be happy and proud of your job!

Job Summary
The Country Trials Manager is responsible for study startup deliverables for assigned studies at a country level that are of moderate to high complexity. For studies where there is more than one country trial manager assigned, may act as the Lead Country Trials Manager for the country or cluster of countries and coordinate all the country activities. The Country Trials Manager partners with the Study Start Up Project Manager, Study Manager, Site Intelligence Lead, Site Relationship Partner, Site Activation Partner, Contracts Lead, Regulatory Affairs, CRO representatives) and others as required. The Country Trials Manager provides leadership and country strategic planning and organization skills to ensure the delivery of operational Start up aspects of one or more studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable.

Accountable for the execution of:

• Country level implementation of Startup and Site Activation Plans
• Country level Recruitment Strategy
• Timely and quality EC/RA Submissions
• Communication with internal stakeholders as listed above to ensure efficient and timely study startup delivery at a country level

Qualifications

Education

• A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels ofeducation/experience: BS/BSc/MS/MSc

Experience

• Extensive operational clinical trial experience

• Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility

• English and region/country local language is required.

• + 7 years of clinical research experience and/or study management/startup project manager experience

• Demonstrated knowledge of site selection, site activation, site readiness interdependencies

• Demonstrated knowledge of clinical trial methodology and the drug development process

• Demonstrated experience leading cross functional teams

• Demonstrated experience in Project Management and Quality Management

• Demonstrated experience in a matrix management environment