Clinical Operations

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Job Title: Clinical Program Manager III

Job Summary

  • The Clinical Research Scientist and Operations Manager (CRSOM) will provide scientific and operational support for multiple global Phase 4 clinical and epidemiologic studies across all vaccine programs within Medical Development, Scientific and Clinical Affairs (MDSCA). Studies may include routine clinical trials, Research Collaborations and non-interventional studies globally. This individual will be responsible for working collaboratively with the Clinical Scientists, Clinical Lead, Medical and Scientific Affairs physicians, to develop study strategies in support of the various vaccine clinical plans. The CRSOM may be responsible for drafting study protocols, informed consents, training materials, and other critical study documents. This individual will also be responsible for managing the operational aspects of the research projects assigned, to ensure high quality management and implementation of clinical research collaborations and other company-sponsored research initiatives. They will be responsible for coordinating activities and deliverables for all assigned projects within the Clinical Affairs group. They will liaise with members of the extended MDSCA team, as well as with other Pfizer partners including, but not limited to, Development Operations, Regulatory Affairs, Safety & Risk Management, Business Process Owners, Clinical Research Collaboration Liaison, Protocol Operations Lead, Outsourcing & Contracting, Accounts Payable, etc. The individual may also provide project support for cross-functional teams including program Epidemiology Sub-teams. Participate in external communities to influence architecture and technology standards to support company objectives; Years of Experience 5-7.

Job Responsibilities

  • Responsible for management and maintenance of the master study tracker for MDSCA to ensure accurate and current information is available

  • Contribute to program and project improvement initiatives to drive efficiency and consistency across programs

  • Perform regular and ad hoc updates to the budget tracking system (i.e. Tactical Matrix) to ensure budget forecasting data for MDSCA clinical projects are current and accurate

  • Assist Clinical Scientists with financial planning/forecasting, tracking, reconciliation, invoice requests/submissions/approvals.

  • Generate extracts and/or reports, as needed from applicable system to facilitate reporting and information sharing within and external to MDSCA

  • Liaise with Business Technology partner to improve functionality and usability of the master study tracker as needed

  • Perform system entries and data reconciliation, on behalf of Clinical Scientist team, within the CTMS/Registry, vendor engagement system, department financial tracking systems, etc.

  • Manage operational aspects of epidemiologic and non-interventional projects run by MDSCA

  • 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, laboratory worksheets, supply requests, monitoring plans, etc.

  • Oversee and act as primary contact for vendors, including laboratory and/or clinical research organizations

  • Liaise with external vendors to ensure laboratory supplies and sample shipment arrangements are made in accordance with protocol requirements

  • Prepare study/project timelines and track progress against stated milestones and deliverables

  • Track the company SOP process steps from concept development through study close-out

  • Ensure appropriate documentation is generated and filed for protocol review and approval through the MDSCA review processes

  • Liaise with external collaborators, key opinion leaders, to obtain relevant required documentation need in support of various research activities

  • Establish and maintain study contact lists

  • Manage financial aspects of research projects including, but not limited to, tracking invoicing and payment activities, and alignment with departmental budget forecasts

  • Assist with filing study documents in the appropriate repository (i.e. GDMS, INSPIRE, PTMF)

  • Lead and/or assist in the development of data collection tools and database set-up, applying company standards as appropriate

  • Perform data review, as appropriate, to identify issues of moderate complexity

  • Facilitate team review and discussion of analyses and reports provided by external collaborators

  • 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 the company's SOPs as well as external regulatory requirements is maintained at the study level

  • Ensure compliance with safety reporting requirements for company-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

  • Participate in the review/editing of protocol outlines, protocols, and amendments of moderate complexity in collaboration with the CS Lead, Medical Monitor, Statisticians, and other relevant study team members

  • Create informed consent form templates, and review site prepared informed consents

  • Support the preparation of other clinical documents as required

  • Develop study training materials for sites

  • Conduct specific medical/protocol/safety training at investigator meetings, kick-off meetings, etc., as needed

  • Complete clinical and other relevant operational sections of the Site Reference Manuals, as needed, for the various study types conducted in MDSCA

  • Provide input on country and site feasibility activities

Education & Qualifications

  • Associates with 8-10 years experience

  • Flexible w/ education (associates w/ 8 yrs in clinical research & masters w/ 5 yrs);


  • Medical, Dental, and Vision Insurance

  • 401K Plan with Company Match

  • Life and AD&D Insurance

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Company Description:

Randstad is a $22.5 billion global provider of HR services and the second largest staffing organization in the world. From temporary staffing to permanent placement to in-house, professionals, search & selection, and HR Solutions, Randstad holds top positions around the world and has approximately 31,100 corporate employees working from its nearly 4,700 branches and in-house locations in 40 countries.

We are a company built on a deep network of expertise that crosses industries and geographies. We recognize that talent comes in different forms, that every business has its unique challenges and opportunities. And our recruiting experts are skilled at marrying talent and business‚€”identifying the ideal professionals for an organization's culture and its teams, its needs and its goals.

Salary: $72.19 - 84.93 per hour

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