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Clinical Research Collaborator Liaison


New York, NY
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Job Details

The Clinical and Research Collaboration (CRC) Liaison has primary responsibility for the oversight and management of clinical and research collaborations within assigned Therapeutic Area(s). Clinical and research collaborations are research studies/programs where Pfizer, Inc. partners with an external collaborator(s) to develop, conduct and execute research that would be used to support Pfizer business or regulatory goals. The CRC Liaison will be in support of one or more assets and/or Business/Research Units that engage with external (third party) collaborators that include but are not limited to principal investigators, research organizations, co-op groups, relevant government agencies (e.g., NIH, NCI), other pharmaceutical companies, drug safety monitoring boards, alliance partners, and any vendors that support CRC activities.

The CRC Liaison ensures the timely due diligence review of CRC proposals, contract generation and execution, and forecasts and coordinates drug shipments across the program globally. This due diligence ensures that proper oversight, risk identification and mitigation are addressed before and during these collaborations with third parties. The CRC Liaison also oversees study progress and collaborates with Pfizer colleagues to ultimately ensure compliance with CRC processes, systems and regulations

Internally, the CRC Liaison is the primary Point of Contact for Pfizer colleagues, including TA Medical Teams (within the Business Units and Research Units), Field Medical, PCOs, and Regions, Worldwide Research and Development, Pharmaceutical Sciences, Contracts & Outsourcing, Safety & Risk Management, Outcomes Research, Project Management, Legal, Regulatory, and Finance.

The CRC Liaison also monitors the CRC-related systems and educational needs of internal and external stakeholders to maintain compliance with Pfizer's CRC policies and guidelines as well as external healthcare law throughout the process. The CRC Liaison will champion operational excellence to provide continuous improvement of processes and sharing of best practices and participates in efforts to improve CRC functions globally across an asset program.

**Manages CRC requests from development to close**

+ Partners with the Project Lead and Legal to work with external collaborator(s) to develop research collaboration proposals

+ Supervises initial review for completeness and classification of CRC proposals, entry of information into the CRC system, and requests for additional information or documentation through the entire lifecycle of assigned CRC studies.

+ Liaises with the Project Lead and Legal and external collaborator(s) of CRC proposals, especially those that will require or more sophisticated handling for review and decision. (e.g., proposals from co-operative groups or partnerships)

**Leads CRC Due Diligence Internally**

+ Informs CRC Functional Line Subject Matter Experts about the proposal and manages their due diligence activities on the CRC proposal

+ Manages and facilitates Kick-Off and review meetings of Functional Line SMEs, Project Lead and Legal that review and make decisions about CRC proposals.

+ Ensures appropriate and efficient follow-up of Due Diligence including action items and decisions, developing Task Ownership Matrices and Oversight Plans between Pfizer and external collaborator(s).

**Collaborates with internal and external partners and stakeholders**

+ Responds to queries from Pfizer and RU/BU ELTs about the status of assigned CRC proposals, studies, and CRC policies and procedures and other internal and external stakeholders, as required.

+ Interacts directly with Collaborator(s), research sites, co-operative groups and public or private sector intergroups and networks globally to facilitate process and execution of CRC studies within assigned TA and to ensure compliance with CRC policy, global and local healthcare laws.

+ Partners with the Project Leads to manage relationships with PCO and Regional colleagues as required for management of CRC proposals globally as needed.

+ Works with Reporting and Analytics Lead to provide detailed summaries and reports for asset or TA leadership and informs decisions on the management of CRC programs

**Mediates** **in the generation of CRC contracts**

+ Facilitates and monitors the efficient and accurate creation of contracts and amendments for CRC studies - new or ongoing - with Legal.

+ Liaises with the Project Lead and Legal and external collaborator(s) of CRC proposals, especially those that will require or more sophisticated handling for review and decision and due diligence activities for amendments (e.g., proposals from co-operative groups or partnerships)

**Secures** **and manages clinical supplies and vendors**

+ Forecasts study drug supply requirements, and initiates requests for clinical supply.

+ Works with PharmSci colleagues to maintain adequate drug supplies, including pooled supplies when feasible and appropriate.

+ Manages study drug supply inventories, and ensures timely deliveries to sites.

+ Monitors study milestones and requests for additional supply and funding.

**Manages financial payments and tracks study progress and close**

+ Initiates initial and milestone payments, as appropriate, working with Finance to ensure accuracy and timeliness.

+ Conducts enrolment sweeps on a regular basis to track patient enrolment and study progress.

+ Evaluates study progress reports and results for overall compliance and recommends corrective action or study termination for non-performance.

+ Secures study results, required documentation, and publications from completed studies and implements Close procedures.

+ Works with the Collaborator(s), Development Operations and other Pfizer colleagues to conduct data transfer activities in preparation for regulatory filings

**Applies and provides training in CRC operational strategies and compliance regulations**

+ Adheres to applicable SOPs, written standards, working practices, and implementation guidelines for the CRC process, as required and contributes to their development.

+ Trains Project Leads and Functional Lines SMEs on CRC policies, procedures, and systems

+ Participates in task forces to evaluate and continuously improve CRC processes and systems, as required and shares best practices.


+ Minimum of a BS/BA is required with preference for a focus in science or biomedical discipline. (Candidates with equivalent experience as defined below may be considered)

+ Master's degree, Advanced education and/or training/experience preferred.

+ Prior Experience in clinical study management or research collaborations is required

+ Demonstrated effectiveness in working in a multidisciplinary, matrix team situation, and demonstrated ability to manage change.

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

+ Strong knowledge of Therapeutic Area(s), subject matter expertise and international experience are desirable.

**EEO & Employment Eligibility**

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.

**Sunshine Act**

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.

**Additional Offer Details:**

+ Last date to apply for this job is 11/24/17

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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