Central Risk Manager (Central Monitoring-Rbm)

2+ years

Not Disclosed

Remote

10 March 3, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Central Risk Manager (Central Monitoring-RBM)
Updated: February 28, 2025
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25001978

Description:

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights, speed therapies to patients, and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything we do. We continuously look for ways to simplify and streamline our work to not only make Syneos Health easier to work with but also to make us easier to work for.

Job Responsibilities:

Provide advice and subject matter expertise for the development of the monitoring strategy required for the project.
Advise the project team on updates to the monitoring strategy based on identified risks.
Work with cross-functional leads to understand complex indications and risks and provide guidance to ensure consistency within programs, therapeutic areas, and sponsors.
Draft initial risk assessment and support the project team in ensuring cross-functional involvement in the finalization of the Risk Assessment Categorization Tool (RACT).
Ensure risks identified are correctly tracked and support ongoing cross-functional review of risks throughout the project.
Provide advice on the development of functional plans to mitigate identified risks.
Assess available tools to conduct remote data review and centralized statistical monitoring, identifying risks to data quality and integrity.
Facilitate review of findings with the internal cross-functional team and sponsor.
Collaborate with team members and the sponsor to identify Quality Tolerance Limits where required.
Develop and deliver training to the study team regarding risk assessment, centralized monitoring, and the wider risk-based monitoring strategy.
Coach and mentor peers regarding functional delivery, evaluation of project risks, and action implementation.
Collaborate with functional areas to ensure risks identified in compliance and delivery according to protocol, ICH/GCP, Good Pharmacoepidemiology Practices (GPP), and country regulations.
Ensure inspection readiness for risk assessment and centralized monitoring scope.
Understand study scope of work, budget, and protocol content for assigned studies.
Escalate any risk assessment and centralized monitoring deliverables (timeline, quality, and budget) at risk to the Project Manager (PM).
Participate in business development activities, including monitoring strategy and budget input, defining meetings, and proposal development.

Qualifications:

Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
Master’s degree or health data sciences degree preferred.
Expertise in Good Clinical Practice/ICH E6 (R2) Guidelines and other applicable regulatory requirements.
Strong knowledge of Risk-Based Monitoring Strategies, Integrated Quality Risk Management (IQRM) theories, and tools.
Proficiency in MS Excel (sorting, filtering, calculating, pivoting).
Mastery of Analytical Data Visualization Tools (adjusting visualizations, selecting subsets of data to analyze, identifying trends and outliers).
Knowledge of statistical analysis techniques, Cluepoints, Medidata-CSA, Hy’s Law, Funnel Plots, and Box and Whiskers.
Knowledge of Lean Six Sigma, RACT tools.
Strong analytical and problem-solving skills.
Well-developed therapeutic expertise.
Excellent verbal and written communication skills.
Strong negotiation and organizational skills.
Demonstrated leadership, tactical and strategic thinking skills.
Ability to anticipate and address critical issues and develop proactive contingency plans.
Knowledge of financial concepts related to forecasting, budgeting, and proposal generation.
Ability to understand and communicate project concepts effectively.
Ability to teach, train, and mentor employees at all levels.
Requires above-average attention to detail, accuracy, and interpersonal skills.
Travel requirement: <30% (departmental meetings, investigator meetings, training, client meetings, and bid defenses).

About Syneos Health:

Over the past five years, we have worked with 94% of all FDA-approved novel drugs, 95% of EMA-authorized products, and over 200 studies across 73,000 sites and 675,000+ trial patients.

Additional Information:

Tasks, duties, and responsibilities listed in this job description are not exhaustive and may be modified by the company as needed.
The company is committed to compliance with global regulatory requirements, including the EU Equality Directive and the Americans with Disabilities Act, ensuring reasonable accommodations when appropriate.

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Central Risk Manager (Central Monitoring-Rbm)

Job Description

Description:

Job Responsibilities:

Qualifications:

About Syneos Health:

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