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Regional Clinical Site Lead I (Manager)

Pfizer


Location:
New York, NY
Date:
08/17/2017
2017-08-172017-09-15
Job Code:
1607564
Pfizer
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Job Details

Job Title Regional Clinical Site Lead I (Manager)

JobID 1607564

Location: New York, NY

Description 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.



**ROLE RESPONSIBILITIES**

In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.

**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 INSPIRE network) that would be supportive of the evolving geographic footprint for the current portfolio



**BASIC QUALIFICATIONS**

Bachelors degree 10+ years experience

Masters 7+ years experience

PhD 3+ experience

Extensive knowledge of clinical trial methodologies

Must be fluent in English.

Multi Language Capabilities are an advantage in this role.



**PHYSICAL/MENTAL REQUIREMENTS**



+ 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



Additional Details:

Eligible for Employee Referral Program

Grade 10

Can be remote based



Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.



Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.



A career at Pfizer offers opportunity, ownership and impact.



All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



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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