Epidemiology Study Manager

We are looking for an Epidemiology Study Manager! Non-interventional or observational study experience required.

Job Purpose:

The Study Manager (SM) supports 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).

Key Accountabilities:

Clinical Trial Operational Delivery

• 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

Compliance with Parexel Standards

• Complies with required training curriculum

• Completes timesheets accurately as required

• Submits expense reports as required

• Updates CV as required

• Maintains a working knowledge of and complies with Parexel processes, GPPs and other applicable requirements

Skills:

• Solid project management and prioritization skills

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

• Proficient in written and spoken English

• Proficient in local language (as applicable)

• Willingness to travel as required for key company meetings

Knowledge and Experience:

• Pharmaceutical experience beneficial but not required

• Therapeutic Area (TA)-specific experience beneficial

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

• Basic knowledge of epidemiologic or outcomes research

• MS Office Suite Experience Required– including Word, Excel, and Power Point

Education:

• Bachelor's degree required / Master's degree (preferred) in public health (or closely related discipline, such as biostatistics, epidemiology, health administration or biological sciences)