Syneos Health

StudyManager

North Carolina, United States FULL TIME Remote Friendly
The Brief

“Study Manager at Syneos Health. Skills: Project Leadership, Study Management, Client Relations. Manages a project as a project manager. Ensures compliance with GCP, relevant SOP’s, and regulatory requirements”

What You'll Achieve.

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

proactively identify and manage issues; Developing contingency planning and 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, Excellent communication, presentation, interpersonal skills, both written and spoken

Nice to Have

Clinical research organization (CRO) and relevant therapeutic experience, Direct therapeutic area expertise, Ability to embrace new technologies

What You'll Do.

Manages a project as a project manager

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

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 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 business

May participate in bid defense meetings

May be required to line manage other project management team members

How You'll Work.

Team & Collaboration

Acts as a primary liaison between the Company and the Customer; Lead project team to ensure quality, timelines and budget management; Coordinate activities and deliverables of all study conduct partners; May be required to line manage other project management team members and clinical monitoring staff

Communication Scope

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

Process & Methodology

Project Leadership and Delivery, timelines and budget management, financial performance of each project, project plans, project management reports, risk mitigation strategies

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