Sr. Spclst, Project Management

Job Description

Role Summary

• The Senior Specialist, Research Manager, position resides in the Value & Implementation (V&I) organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research.

• The Non-Interventional Research Management team provides support across all elements of management and execution of non-interventional studies and research activities.

• This position, under the supervision of an Associate Director or above, will execute a variety of research management activities from study execution to closeout and summarization of results from observational-research activities. Research managers are aligned by department/therapeutic area (TA) for activities under V&I Plans.

Responsibilities and Primary Activities

• Coordinates all aspects of observational or non-interventional research activities, which includes the implementation of primary-data collection, chart review/survey, and database studies; health economic model development and adaptations; and other activities in support of Health Technology Assessment (HTA).

• Supports scientist(s) by providing overall operational support for research conduct in compliance with Good Pharmacoepidemiology Practice (GPP), company policies, and standard operating procedures (SOPs).

• Provides operational support of observation or non-interventional research activities, including execution and closeout of primary-data collection, chart review, and database studies in addition to other activity types.

• Manages several complex activities and study types.

• Liaises with and provides oversight/direction to supplier and communicates with internal cross-functional teams to share project status and mitigations.

• Tracks timelines/deliverables and follows up on action items (vendor and internal teams/scientists).

• Assists with review and finalization of all supplier documents, such as monitoring, project management, safety management, data management, and validation plans.

• Participates in protocol and interim/final report preparation, shepherds documents through the internal review process for approval, and submits to the internal repository.

• Coordinates internal/external meeting management and drafts/reviews agendas and minutes.

• Ensures that studies follow all non-interventional processes for informed consent, compliance, site contract and budget review/approval, protocol document review, study registration (when applicable), adverse-event reconciliation, publication submission, and closeout.

• Coordinates confidentiality and consultant agreements, as well as external engagement meetings.

• Participates in quality control and integrity of study data and reports for publications.

• Manages publication development, including formatting, figure/data content development, co-author review, internal review process, and journal submissions.

• Collaborates and troubleshoots issues by providing potential resolutions when necessary to ensure timely management and execution of activities.

• Participates in internal process-improvement initiatives with Research Management and mentors other research managers as necessary.

 

Required Qualifications, Skills and Experience

Minimum

• Bachelor's degree in life sciences or public health (or closely related discipline, such as epidemiology, health administration, or biological sciences).

• At least three to five years of work experience within clinical/observational research or equivalent.

• Ability to understand, describe and document (when applicable) procedures/compliance requirements for observational studies to internal and external stakeholders such as outside investigators/suppliers and key opinion leaders.

• Excellent communication and interpersonal skills; ability to collaborate with a wide variety of stakeholders.

• Basic knowledge of epidemiologic or outcomes research.

• Strong project management and prioritization skills.

• Motivation and ability to work independently and collaboratively.

• Proven ability to be solution-oriented, detail-oriented and timely.

• Ability to manage a high volume of complex research activities.

Preferred

• Master's degree in life sciences or public health (or related discipline such as epidemiology, health administration, or biological sciences).

Required Skills:

Adaptability, Adaptability, Biological Sciences, Budget Development, Change Manageme