Syneos Health · 9 hours ago
FSP Clinical Scientist
United States
Full-time
Remote
Mid LevelSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The FSP Clinical Scientist will perform medical and scientific data review on hematology clinical trials, support the Lead Scientist with scientific data review, and collaborate with study team members to ensure project milestones and timelines are met.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Perform medical and scientific data review on haematology clinical trials (indication anticipated myeloma or lymphoma)
Standard data listing review (data listings, AEs, con meds etc)
May complete patient profile review, standard listing data review, efficacy review and safety narrative review, PD analysis and PD review
Will support Lead Scientist with scientific data review of clinical trial
May support with additional CS tasks beyond scope of data review at the discretion of the Lead CS team however the primary role will be scientific data review
Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan). Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans
Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews
Authors medical data queries and reviews query responses, approves query closure in association with Medical Director
May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed
Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed
Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met. Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review
Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management (set-up and/or lead meetings as appropriate) to identify risks related to data integrity and subject safety. Escalates ongoing and newly developed study concerns such as at-risk project deliverables and out of-scope tasks to the project leads in a timely manner
Attends at Trusted Process meetings and may participate in internal and external audits
Acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology
Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs), all enterprise policies, standard operating procedures, work instructions, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans
Qualification
Required
Degree in life sciences (MSc, PharmD, PhD, DMD, MD) or equivalent with relevant scientific experience and/or training discipline
Excellent time management skills to handle multiple tasks and meet deadlines while delivering high quality work in a highly regulated and dynamic environment
A self-starter and comfortable with fluctuating timelines, work demands and changes in scope of work
Ability to troubleshoot situations as needed and understands when issues or questions need to be escalated to the leadership
Understanding of scientific principles to assure effective and high-quality medical data analysis
Excellent written and oral communication skills
Excellent computer skills: MS Office programs, spread sheets, presentations
Strong team player with excellent interpersonal skills and ability to work effective in a cross-functional team environment
Preferred
Knowledge of drug development
Demonstrated proficiency with ICH/GCP guidelines
Benefits
Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Total Self culture
Company
Syneos Health
Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.
Founded in 1985
10001+ employees
H1B Sponsorship
Syneos Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (35)
2024 (26)
2023 (49)
2022 (63)
2021 (84)
2020 (63)
Funding
Current Stage
Public CompanyTotal Funding
$524.65M2023-09-28Private Equity
2023-05-10Acquired
2021-03-01Post Ipo Secondary· $524.65M
Leadership Team
Costa Panagos
Chief Executive Officer
Michael Bonello
Executive Vice President and Chief Financial Officer
Recent News
2026-01-09
Company data provided by crunchbase