Global Project Manager
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: New York • United States
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About the role
- Direct liaison with CROs and other vendors to manage relevant trial(s) operational tasks
- assists in the review, development and writing of clinical trial documents and manuals and other supporting documents
- create Master ICF template and review/approve sites changes
- participate in the feasibility and evaluation of investigative sites
- coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization
- assist in the development and management of study timelines and priorities, including recruitment tools/strategy and patient retentions plan
- plan and organize meetings with team support
- assist in the development of the IP and co-medication strategy
- participate in data review and discrepancy resolutions
- participate in coordinating efforts with internal pharmacovigilance and safety group
- monitor study-specific timelines and key deliverables; focus on management of all external vendors
- participate as a member of the multi-disciplinary trial team
- develop relationships with investigational sites and institutions to enhance conduct of the trial
- acts as preliminary liaison for study sites to convey trial information
Requirements
- Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience
- at least (5) years of relevant experience as Global CTM Clinical research organization (CRO)
- ONCOLOGY therapeutic experience preferred
- Early phases preferred
- Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
- Strong organizational skills
- Strong ability to manage time and work independently
- Ability to embrace new technologies
- Excellent communication, presentation, interpersonal skills, both written and spoken
- Ability to travel as necessary (approximately 25%)
Benefits
- company car or car allowance
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- flexible paid time off (PTO) and sick time
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial managementclinical trial documentationdata reviewdiscrepancy resolutionstudy timeline managementrecruitment strategypatient retention planningpharmacovigilanceGood Clinical PracticeICH guidelines
Soft Skills
organizational skillstime managementindependent workcommunication skillspresentation skillsinterpersonal skills