Job Description
Overarching Responsibilities:
It is business critical that our company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. REAIM organization brings our company into a state of the art model and new ways of working to manage Risk and central analytics and ensure exquisite oversight of our clinical trials. Under the oversight of Risk Evaluation and Adaptive Integrated Central Analytics Lead (RAL) the Assoc. RECAM is responsible for the conduct of sound risk evaluation and central analytic principles incorporation into the assigned trials.Among key responsibilities are:
• RISK EVALUATION AND CENTRAL ANALYTICS
Is responsible of ensuring that sound risk evaluation and central analytic principles are incorporated into the assigned trials in support of regulatory filings. This includes operational risk evaluation and central analytics execution in assigned protocols:
o Support to AIM system/software validation and maintenance,
o Maintenance of Quality Tolerance Limit (QTL) analysis, Key Risk Indicator (KRI) study analysis and Central Statistical Analytics components and risk identification principles in assigned clinical trials
o Support preparation of configuration plans for Risk Analysis components from both business and technical perspective, ensuring Risk Analysis modules reflects protocol changes
o Assessment of potential Study changes affecting Risk Analysis
o AIM adoption and alignment across all study plans (i.e. Site Monitoring, Data
Management, Quality Management etc.)
Ensures consistent and standard processes in REAIM are used across our company teams in the assigned trials, and that processes meet worldwide regulatory guidelines.
• CENTRAL MONITORING PLANS
Responsible for the maintenance of Central Monitoring Plans (CMP) and the applicable design specifications for Risk Analysis components from both business and technical perspective and for the cooperation with the Supplier’s Support Team during configuration of those, leading the facilitation of discussions with the Clinical Trial Team as applicable Executes central analytics & monitoring activities as outlined in CMP, including QTL and KRI
analysis and Central Statistical Analytics aligned with critical data, process and risk assessments, to support identification of important study issues and risks which require monitoring, management and adaptation of study plans during study conduct (taking part in risk reassessment process)
• COLLABORATION
Responsibilities include interaction with stakeholders in Global Clinical Development (GCD) and GCTO like: Medical Monitors, Clinical Scientists, Clinical Quality Operations Managers (CQOMs), Global Data Management Standards (GDMS), Biostatistics And Research Decision Sciences (BARDS) Statisticians and rest of members of the Clinical Trial Teams (including Country roles).
• REAIM STRATEGY
Contributes to the standardization of REAIM procedures, tools and templates to ensure consistency and seamless progression through the study lifecycle.
Minimum education required:
Bachelor’s/ Master’s Degree or equivalent with strong emphasis in science and/or biology. Minimum B.A. or B.S. degree, preferably in Data Science, Statistics, Pharmacy, Nursing, Biological Sciences, or health care related discipline.
Required experience and skills:
- Relevant 2-6 years experience in clinical research and data analytics.
- Experience with risk management tools and processes within the clinical quality framework.
- Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively in an international environment
- Excellent understanding and working knowledge of clinical research, phases of clinical trials, International Conference on Harmonization Good Clinical Practice (ICH-GCP) E6 risk-based quality management (RBQM) methodology and worldwide Regulatory Health Authority requirements and Good Documentation Practices.
- Demonstrated high level of monitoring skill with independent professional judgment.
- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
- Ability to understand and analyze data/metrics and act appropriately, also in a virtual environment.
- Demonstrated teamwork and leadership skills, including conflict resolution expertise and discretion.
- Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
- Able to work highly independently across multiple protocols, sites and therapy areas.
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Ability to proficiently interact with all levels of specialists & management and exert influence to achieve results.
- Ability to think cross-functionally and working across boundaries internationally.
- Demonstrates commitment to Customer focus.
- Works with high quality and compliance mind-set
- Possess Data Literacy skill sets: i.e. have the ability to read, understand, create, and communicate data as information.
