Study Operations Assistant

hace 7 meses

San José, Costa Rica Pfizer A tiempo completo

:
The Real World Evidence (RWE) platform Study Operations Assistant (SOA) will provide operational support for the RWE platform. This individual will be responsible for providing support to project teams by working collaboratively with the Clinical Scientists, Study Operations Managers, RWE Scientists, Medical Lead and Scientific Affairs Leads, Global Access and Value lead, etc. The SOA will be responsible for the baseline operational support in compliance with applicable SOPs and including activities such as collecting and maintaining project financial information for overall project budget and forecast tracking, maintaining accurate updates in specified systems, preparation and facilitation of basic study documents (i.e., Confidentiality Disclosure Agreements), updating and maintaining organization in team document spaces, and other department wide operational activities as required to help on team initiatives. The SOA will liaise with members of the extended RWE platform team, especially the Clinical Scientist as well as with other Pfizer partners.

POSITION RESPONSIBILITIES:

- Support the studies (Non-Interventional Studies, Low Interventional Studies, Research Collaborations, etc.) and projects via conduct of basic operational tasks across the RWE platform by working collaboratively with involved departments and groups
- Perform operational responsibilities for assigned tasks in compliance with Pfizer policies and procedures
- Support financial aspects of assigned studies or research projects including, but not limited to:

- Entering, updating, and maintaining financial information into tracking tools (spreadsheets, forecasting systems, etc)
- Tracking invoicing and payment activities to respond to queries
- Providing financial details to address study team or program level requests
- Assisting with provision of study financial details for financial planning
- Tracking study contracts and amendments and entering applicable financial updates to budget/forecast in relevant tools and systems or communicating these changes to the appropriate study and program contacts
- Other financial assistance as needed by study or program team
- Maintain study details in required systems as necessary from concept to close-out (Siebel, SToD, RAPID, Planisware, etc)
- Assist with maintenance of study master file and file study documents in the appropriate Pfizer repository (i.e. GDMS, PTMF, etc)
- Facilitate execution of Confidentiality Disclosure Agreements
- Schedule, participate in and take minutes during scheduled team meetings (if required) - distribute minutes, action items, follow-up for completion as needed
- Create or assist with study documents as requested by Clinical Scientist or Study Team (MS Word, Excel, PowerPoint)
- Create folders and file documents in shared drive locations (SharePoint, Teams, etc) for Study Team to actively manage the project
- Prepare and assist others with required internal study documents including, but not limited to, concept submission, due diligence checklist, laboratory worksheets, supply requests, study team rosters, vendor lists, etc.
- Support audits/inspections as applicable
- Assist with other department or platform needs and activities as requested

EDUCATION AND EXPERIENCE:

- BA/BS degree and 1-3 years of prior relevant experience is required;
- Experience with participating in and supporting a multidisciplinary team
- Ability to work independently with mínimal supervision
- Fluent in English with exceptional written and oral communication and cross-functional collaborative skills
- Outstanding organizational skills, managing several projects concurrently that are often time pressured; strong ability to effectively multi-task and prioritize
- Proficiency in MS Word, Excel, and PowerPoint

Work Location Assignment: Flexible

EEO (Equal Employment Opportunity) & 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, or disability.

Medical

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