The I&I Evidence Generation Operations Senior Manager
(OSM) will provide scientific and operational support for research studies across all therapeutic areas within I&I Medical Affairs. Studies may include independent research grants, Research Collaborations, and observational studies (non-interventional/ Low interventional) conducted by local and global I&I colleagues.
This individual will be responsible for working collaboratively with the I&I Evidence Generation Lead, and liaise with Global and Regional Medical Affairs, Medical Excellence, GPD, Safety, Procurement, PHI RWE COE and Value and Evidence, and relevant Business Process Owners including CT24 and identify operational needs and resolve challenges/issues. This role will design and socialize an operations strategy to ensure adherence to Pfizer policies and procedures and quality in the process. The OSM will be responsible for drafting and or reviewing study protocols, training materials, and other essential study documents.
This individual will mainly be responsible for managing the operational aspects of the research projects assigned: Pfizer-sponsored research initiatives and applications of CT-24 as appropriate. This person will also be responsible for coordinating activities and deliverables for all assigned projects (CT 24, RC01, GNT01 etc) within the medical affairs group. The individual may also provide some project support related to contract development and budget management.
This individual may also lead the development and or maintenance of new/ existing Evidence generation tools and dashboards
This position is part of the Evidence Generation team within I&I Medical Capabilities Group and reports directly to the Evidence Generation Lead.ROLE RESPONSIBILITIES 1. OPERATIONAL
2. STUDY IMPLEMENTATION
- Participate in the discussion of study designs and/ or reviewing of protocols, and amendments of moderate complexity in collaboration with the study Lead, Medical affairs colleagues, Statisticians, and other relevant study team members
- Review and create essential study documents as needed.
- Develop or conduct study training relevant and applicable to evidence generation GSOPs
- Complete operational activities and best practices as needed, for the implementation of studies under NIS CT-24, RC01, grants etc
- Responsible for vendor oversight as applicable, includingclinical research organizations (CROs) to ensure compliance with CP102, QMS09 GSOP and all associated applicable GSOPs.
3. STUDY OVERSIGHT
- Manage operational aspects of epidemiologic and non-interventional projects run by medical affairs
- Facilitate and coordinate the selection of the appropriate study implementation pathway (i.e. SOP selection)
- Prepare required study documents including, but not limited to, concept submission, due diligence checklist, etc.
- Oversee and act as primary contact for vendors, including clinical research organizations (CROs)
- Track Pfizer SOP process steps from concept development through study close-out
- Liaise with external collaborators, key opinion leaders, to obtain relevant required documentation need in support of various research activities
- Manage financial aspects of research projects including, but not limited to, tracking invoicing and payment activities, and alignment with departmental budget forecasts.
4. DEPARTMENT LEVEL SUPPORT
- Lead and/or assist in the development of data collection tools and database set-up, applying Pfizer standards as appropriate
- Provide guidance and feedback to sites regarding protocol implementation
- Participate in any internal or external audits that may occur on an assigned project
- Ensure compliance with Pfizer SOPs as well as external regulatory requirements is maintained at the study level
- Ensure compliance with safety reporting requirements for Pfizer-sponsored non-interventional studies
- Review vendor/collaborator monitoring plans, study quality plans, data review plans, and other relevant oversight documents to ensure data integrity and compliance in compliance with Pfizer SOPs.
- Generate extracts and/or reports, as needed to facilitate reporting and information sharing
- Liaise with Business Technology partner to improve functionality and usability of the operations platform as needed.
- Proactively works with other key stakeholders to enable the study process (e.g., Global, local and Regional I&I Medical Affairs, Medical Excellence, GPD, Safety, Procurement, PHI RWE COE and Value and Evidence, Grants team and relevant Business Process Owners including CT24), identify operational needs and resolve challenges/issues.
- Minimum Bachelor's degree in science, health-related field or epidemiology, or 7 years of equivalent relevant experience is required
- 7- 10 years of prior clinical trial, non-interventional study and/or Real -world evidence study experience required.
- Experience participating in and supporting a multidisciplinary team
- Flexibility to engage global team members and stakeholders in disparate time-zones
- Strong working knowledge of the technical and methodological aspects of registries and observational study: design and implementation.
- Experience in project management: (contracting, budgeting, vendor management) essential. Demonstrated ability to manage multiple projects (multitask) involving complex processes, significant budget, competing deadlines and rapidly shifting priorities.
- Ability to work independently with minimal supervision
- Exceptional written and oral communication and cross-functional collaborative skills
- Proficiency in MS Word, Excel, and PowerPoint
- Excellent interpersonal skills required: ability to understand and respond to multiple internal and external stakeholders.
OTHER JOB DETAILS:
- MS/ MD preferred
- Experience working with Pharma industry
- Experience with registries, RWD data sources, RWE studies etc.
- Last day to apply: October 11, 2022
Relocation assistance may be available based on business needs and/or eligibility.Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.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. 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.