Description
The Risk Manager (Clinical Research) plays a pivotal role in developing and executing risk-based monitoring strategies, ensuring data quality and integrity in clinical research projects. This position involves cross-functional collaboration to identify, assess, and mitigate risks throughout the clinical trial lifecycle, supporting the seamless implementation of Risk-Based Study Management (RBSM) principles in a CRO or pharma industry.
RESPONSIBILITIES
More specifically, the Risk Manager must:
- Provide subject matter expertise for developing and updating the risk-based monitoring strategy tailored to project needs.
- Collaborate with cross-functional teams to identify and mitigate risks associated with complex indications.
- May have to coordinate with central monitor team and verify work.
- Point sur provide budget recommendations, change orders.
- Draft initial risk assessments and support the finalization of Risk Assessment and Categorization Tools (RACT).
- Guide Project Managers (PMs) in transferring identified risks to the appropriate tracking systems and ensure ongoing reviews.
- Advise on developing functional plans to mitigate risks effectively.
- Utilize available tools to conduct remote data reviews and centralized statistical monitoring, identifying risks to data quality and integrity.
- Facilitate internal and sponsor reviews of findings, seeking cross-functional support for complex risks and mitigations.
- Deliver initial and ongoing training for study teams on risk assessment, centralized monitoring, and risk-based monitoring strategies.
- Escalate risks or deliverables at risk to the PM, including scope changes.
- Provide strategic input on risk characterization and reporting to leadership.
- Take on additional responsibilities as required, ensuring qualifications and training align with assigned tasks.
Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
Requirements
Education
- Bachelor’s degree in a field relevant to clinical research;
Experience
- Must have experience in a CRO or pharma industry
- Minimum of 3 years in risk management within a clinical research setting.
- Minimum 5 years of experience across clinical monitoring, data management, drug safety.
Requirements:
- Expertise in Good Clinical Practice/ICH E6 (R3) Guidelines and other regulatory requirements.
- Proficiency in Risk-Based Monitoring strategies, processes, and tools.
- Mastery of MS Excel (sorting, filtering, pivot tables).
- Advanced skills in analytical data visualization tools.
- Knowledge of Lean Six Sigma and web based RACT tools.
- Strong analytical and statistical understanding.
- Excellent communication, negotiation, and leadership skills.
- Ability to anticipate critical issues and develop proactive contingency plans.
- Skilled in project workflows and cross-functional collaboration.
- Training, mentoring, and organizational capabilities.
- High level of autonomy.
- Fluent in English (excellent oral and written).
- Must be able to communicate clearly and effectively at all levels within the organization and with external customers.
- Must be a fast learner and able to understand new concepts quickly.
- Prioritization skills with the ability to plan, monitor, and manage workload fluidly in response to changing project demands.
- Excellent understanding of project protocol, project documentation including centralized monitoring and risk-based monitoring.
- Broad working knowledge of the roles, functions and process of conducting clinical trials.
- Must be able to manage time effectively, working with multiple functions and requirements.
- Must have been involved in the use of trial management or data management systems.
Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
Our company
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
- Flexible work schedule
- Permanent full-time position
- Company benefits package
- Ongoing learning and development
- Home-based position
Work location
Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required.
A Global Clinical Leader in Dermatology and rheumatology!
Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.
Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in Canada.
Originally posted on Himalayas