Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
**CORE Accountabilities and Responsibilities:**
It is business critical that our company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. REAIM ( Risk Evaluation & Adaptive Integrated Monitoring) 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 the Risk Evaluation and Adaptive Integrated Central Analytics Lead (RAL), the 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 all operational risk evaluation and central analytics management:
+ AIM system/software validation and maintenance,
+ Implementation of central analytics & monitoring activities, including Quality Tolerance Limit (QTL) analysis, Key Risk Indicator (KRI) study analysis and Central Statistical Analytics
+ Preparation of configuration plans for Risk Analysis components from both business and technical perspective, ensuring Risk Analysis modules reflects protocol changes
+ Assessment of potential Study changes affecting Risk Analysis
+ 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.
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 re-assessment process).
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).
Contributes to the standardization of REAIM procedures, tools and templates to ensure consistency and seamless progression through the study lifecycle.
**Position Qualifications** **:**
**Education Minimum Requirement:**
+ 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.
+ 2 year's experience in clinical researchand 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 requirementsand 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.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
**Who we are ...**
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
**What we look for ...**
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
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In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Flexible Work Arrangements:**
Remote Work, Telecommuting, Work Week
1st - Day
**Valid Driving License:**
**Number of Openings:**
**Requisition ID:** R215589
- Clinical Research
- Clinical Trials
- Clinical Works