Syneos Health

StudyManagerOphthalmology

North Carolina, United States FULL TIME Remote Friendly
The Brief

“Study Manager - Ophthalmology at Syneos Health. Manages a project as a project manager overseeing interdisciplinary clinical research studies. ensures compliance with GCP, relevant SOP’s, and regulatory requirements”

What You'll Achieve.

accelerate customer success; address modern market realities; ensure timely study launch, conduct, and closeout; ensure quality, timelines and budget management; ensure successful delivery of study goals

Industry & Context.

Problems you'll solve

problem solvers; risk mitigation strategies

Eligibility Requirements

Ability to travel as necessary (approximately 25%)

What They're Looking For.

Must Have

Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience, knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements, organizational skills, ability to manage time and work independently, Ability to embrace new technologies, Excellent communication, presentation, interpersonal skills, both written and spoken

Nice to Have

Clinical research organization (CRO) and relevant therapeutic experience preferred, Direct therapeutic area expertise

What You'll Do.

Manages a project as a project manager overseeing interdisciplinary clinical research studies

ensures compliance with GCP

and regulatory requirements

Acts as a primary liaison between the Company and the Customer

Lead project team to ensure quality

timelines and budget management

Accountable for the financial performance of each project

Coordinate activities and deliverables of all study conduct partners

proactively identify and manage issues

Ensure studies are conducted in compliance with GCP

relevant SOP’s and regulatory requirements

Accountable for all project deliverables for each project assigned

Responsible for quality and completeness of TMF for assigned projects

Accountable for maintenance of study information on a variety of databases and systems

Responsible for study management components of inspection readiness

Oversight for development and implementation of project plans

coordinate and present at internal and external meetings

Prepare project management reports for clients and management

Developing contingency planning and risk mitigation strategies

Develops relationships with current clients to generate new and/or add-on business

May participate in bid defense meetings

May be required to line manage other project management team members

How You'll Work.

Team & Collaboration

collaborate with passionate problem solvers, innovating as a team

Communication Scope

Excellent communication, presentation, interpersonal skills, both written and spoken

Process & Methodology

Project Leadership and Delivery, timely study launch, conduct, and closeout, budget management, project management reports

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