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Regional Clinical Site Lead I

Pfizer


Location:
Sofia, Sofia City Province 1407
Date:
11/20/2017
2017-11-202017-12-21
Pfizer
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Job Details

The Regional Clinical Site Lead is responsible for in country site management and clinical/medical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices, and Pfizer standards.



This Regional Clinical Site Lead role is accountable for managing investigator site relationships to ensure effective delivery of clinical trials (e.g. study start up, enrollment, database release), to safeguard the quality of investigator sites (e.g. site health, patient safety) and to maintain investigator and study coordinator engagement and satisfaction.



The Regional Clinical Site Lead is the local expert for the assigned clinical trials and brings that expertise to support the investigator site, which includes the investigator, study coordinator, pharmacist etc, and to oversee and support the site monitor in the conduct of clinical trials. This role is responsible for the resolution of protocol-related issues at the local level.



The Regional Clinical Site Lead is the in country Global Product Development interface with the local country/regional medical affairs teams. When necessary, the role interfaces with the study team and is the conduit from the study team back to the regional clinical site management function. This role supports the Study Team by providing regional / country insights and updates on the evolving local clinical development environment as well as cross-site insights regarding study performance.



The Regional Clinical Site Lead also supports the local clinical development environment to enable Pfizer's interest in clinical development and scientific leadership to be demonstrated. This role is key in providing cross study, and cross site insights into the Clinical Development Portfolio at the country/cluster level.







**Main Responsibilities**



Responsible for country site management and clinical/medical/scientific oversight for assigned studies:



**Site Management & Delivery**



Provide country level input to country strategy, feasibility and protocol design in collaboration with relevant Medical Affairs colleague, and with input from external clinical experts as required.



Provide recommendations on potential sites and provide targeted follow up with key sites as required.



Oversee and support study start up activities at the country level, including review of key documents (eg local Informed Consent Document template), and providing support to address regulatory and/or ethics committee questions.



Oversee and support study start up activities at the site level, including management of emerging issues that may compromise time to site activation.



Provide enrollment support and ensure progress by responding to start-up and recruitment issues from investigators, partner with study team to define and support recruitment initiatives at site / country level



Lead effective site recruitment planning and implementation of plans at the country and site level, consistent with global plan and local specificities



Support database release as needed.



**Clinical/Medical/Scientific Oversight**



Be proactive in ensuring overall site quality, regulatory and Good Clinical Practice compliance.



Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators and site monitors.



Provide protocol training to, and address protocol related questions from, the investigator site staff and site monitor when required. This may include attendance at investigator meeting and/or site initiation visits. This should involve discussions on known/anticipated operational and clinical risks



Create and manage the study site risk plan (the site health oversight plan) and mitigate for known/anticipated risks proactively



Monitor site performance using appropriate tools and resources (e.g. metrics, site health, Risk Based Monitoring signals etc) and take appropriate targeted action.



Apply knowledge of data and analytics to target site, study and asset level actions for mitigation and control.



Conduct and report oversight activities, both remote and onsite visits according to Pfizer standards.



Proactively identify, manage and escalate site issues.



Help to address Significant Quality Events or other quality issues at patient and/or site level.



Ensure resolution of investigator site issues in order to maintain sound investigator relations.



Communicate with investigators and study coordinators on a regular basis to build and maintain productive relationships and support investigator engagement through medical and scientific discussion.



Provide support for site audits/inspections as needed.



Maintain a thorough knowledge of assigned protocols.



Demonstrate TA/Category expertise where appropriate.



Colleagues with MD equivalent qualification and required experience will take on medical monitoring responsibilities, including participation in 24/7 medical cover, being the local point of contact for medical issues and assisting with complex safety, eligibility and other patient or protocol issues



**Study Team Interface**



Interface with the study team as needed and act as representative of the RCSL function



Champion and ensure update of existing tools / processes related to clinical site selection and management



As needed, facilitate the exchange of information to / from the study team on study progress and impact of local clinical development environment on study / site



Provide regional and cross-regional insights on study-site performance and trends to / from the study team



**Country/Regional Environment Management and Across Study Trends**



Provide regional and cross-regional insights on trends (eg study/asset level issues, cultural differences, evolving local regulatory environment etc)



Maintain a thorough knowledge of country/regional clinical trial regulations and the country/regional clinical development environment



Provide insight on appropriate sites/strategic alignment of networks (eg INS







**Qualifications**



A scientific or technical degree in the healthcare field or an MD / MD equivalent degree along with:



Extensive knowledge of clinical trial methodologies



Must be fluent in English. Multi Language Capabilities are an advantage in this role



In general, candidates for this job would hold the following levels of education/ experience:



BS/BSc/MS/MSc or equivalent with demonstrated clinical research experience



PhD/MD or equivalent with demonstrated clinical research experience



Demonstrated knowledge of clinical research and development processes and ability to gain command of process details



Demonstrated knowledge of global and local regulatory requirements



Demonstrated understanding of key operational elements of clinical research (e.g., site selection, monitoring, data acquisition and cleaning, reporting, etc.)



Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)



Demonstrated ability to participate and support sponsor regulatory interactions/inspections



Demonstrated knowledge of the processes around protocol design and feasibility assessment



Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery



Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial



Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation



Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization







Global Job Level: J070







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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