Study Manager, Epidemiology Operations

Job Description

Support the Lead Epi Scientists by providing overall operational support for study conduct. Responsible for the coordination and execution of observational or non-interventional research studies (including Post Authorization studies) in compliance with Good Pharmacoepidemiology Practice (GPP) and Standard Operating Procedures (SOPs).

Primary responsibilities include:

• Support operational planning and project management of epidemiology research studies

• Support execution and close out of primary data collection chart review database and molecular epidemiology studies in addition to other activities

• Provide vendor oversight including qualification efforts confidentiality agreements specifications and contract reviews

• Liaise with the vendor and cross-functional teams to share project status and/or needs

• Assist with review and finalization of all vendor documents such as the safety management data management communication project management and validation plans

• Participate in protocol and interim/final report preparation shepherd document through the internal review process for approval and upload to department repository

• Coordination of collection international shipment processing by internal/external labs and data transfer for biospecimen- based studies

• Participate in quality control assessments and ensure integrity of study data for reports and publications

• Understand coordinate and document adherence to internal external and regulatory compliance requirements

• Collaborate and troubleshoot issues by providing potential resolutions when necessary to ensure timely management and execution of studies

Education Requirement:

• Bachelors degree required

• Masters degree (preferred)

• Degree in public health (or closely related discipline such as biostatistics epidemiology health administration or biological sciences)

Required experience and skills

• One (1) or more years of work experience within clinical/observational research or equivalent.

• Basic knowledge of epidemiologic or outcomes research

• Solid project management and prioritization skills

• Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholders

Required Skills:

Preferred Skills:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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