Clinical Scientist - Oncology

Syneos Health/ inVentiv Health Commercial LLC; Connecticut; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits (medical/dental/vision

401(k) plan

Employee Stock Purchase Plan

Bonuses based on performance

Flexible PTO

Job summary

Syneos Health/ inVentiv Health Commercial LLC is seeking a Medical Data Review professional to collaborate with the Medical Director in developing comprehensive medical plans and conducting regular data reviews to identify risks and trends. The role involves preparing slides for meetings, coordinating with internal teams, and ensuring deliverables meet milestones and quality standards.

The candidate will participate in audits, gain exposure to protocol designs, and uphold ICH/GCP and data

Responsibilities

• Works with the Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, Eligibility Review Plan).
• Performs regular and ad‑hoc medical review of data listings and data visualizations as needed; analyzes the data to identify risks, data patterns, and trends and supports documentation of medical reviews.
• Authors medical data queries and reviews query responses, approves query closure in association with the Medical Director.
• May assist the Medical Director with patient profile reviews, scientific reviews of other study level data, protocol deviation review, and creation of Medical Review Summary reports 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 project‑specific milestones and timelines are met. Serves as the primary interface between the 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 (setting up and/or leading 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 project leads in a timely manner.
• Attends Trusted Process meetings and may participate in internal and external audits.
• Acquires a 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), Good Clinical Practice (GCP) standards, enterprise policies, standard operating procedures, work instructions, and project plans. Also adheres to customer policies and standard operating procedures as required in project plans.

Job description

Job Responsibilities

• Works with the Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, Eligibility Review Plan). Engages with outside experts, consultants, and advisors to coordinate acquisition of necessary medical/scientific input to prepare the respective medical plans.
• Performs regular and ad‑hoc medical review of data listings and data visualizations as needed; analyzes the data to identify risks, data patterns, and trends and supports documentation of medical reviews.
• Authors medical data queries and reviews query responses, approves query closure in association with the Medical Director.
• May assist the Medical Director with patient profile reviews, scientific reviews of other study level data, protocol deviation review, and creation of Medical Review Summary reports 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 project‑specific milestones and timelines are met. Serves as the primary interface between the 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 (setting up and/or leading 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 project leads in a timely manner.
• Attends Trusted Process meetings and may participate in internal and external audits.
• Acquires a 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), Good Clinical Practice (GCP) standards, enterprise policies, standard operating procedures, work instructions, and project plans. Also adheres to customer policies and standard operating procedures as required in project plans.

Benefits

At Syneos Health, we offer a comprehensive benefits package that may include a company car or car allowance, health benefits covering medical, dental, and vision care, company match 401(k), eligibility to participate in the Employee Stock Purchase Plan, potential commissions/bonuses based on company and individual performance, and flexible paid time off (PTO) and sick time. Eligibility for paid sick time may vary depending on location and applicable state and municipal requirements.

Salary Range

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

Equal Employment Opportunity / EEO Statement

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. The Company also fully complies with the EU Equality Directive and all obligations imposed by legislation in countries where it operates.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.