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
The Country Trials Manager is responsible for study startup deliverables for assigned studies at a country level of limited or moderate complexity. 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
How You Will Achieve It
- PTA and SIV report review
- Supports with implementation of Pfizer’s Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM)
- Collects Country level documents (e.g. Insurance documents, LOA if required) required for submission/SIVs
- Support to EC/RA and other relevant (e.g. identification of National coordinators, radiation, biobanking) submissions and deficiency/query responses for initial and subsequent CSA submissions
- Supports Clinical Study Agreement and budget negotiations and setup of site payment tools
- Country and site level PTMF setup
- Provides country level documents to PTMF and Investigator Site File (ISF) and ensure country level PTMF completeness during study startup
- Country level ICD creation and Global Review and Approval Form (GRAF) completion and site level ICD creation and GRAF completion, if applicable
- Country level IP/equipment/ancillary supplies management including Import/Export License management
- Provides support for the IIP process to Site Activation Partner
- Supports implementation of new tools and technologies (e.g. eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, implementation of protocol required decentralized trial options etc.)
- Identify/contract/Manage/Oversee local vendors or facilities as per protocol
- Investigator Meeting support
Qualifications
Must-Have
- 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 of education/experience: BS/BSc/MS/MSc; a nursing diploma or associate degree in nursing may also be considered with extensive clinical trial experience.
- Operational clinical trial experience
- Expertise in the use of Site Activation tools
- Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
Nice-to-Have
- +5 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
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical