Central Risk Manager

Clinical Monitoring Research Triangle Park, North Carolina Boston, Massachusetts Quincy, Massachusetts Philadelphia, Pennsylvania Baltimore, Maryland Atlanta, Georgia Tampa, Alaska New York, New York


Description

Position at Premier Research Group Limited

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Analgesia, Neuroscience, Oncology, Pediatrics, and Rare Diseases.

We’re looking for a innovative and energetic Central Risk Manager to join our team! This is a very exciting opportunity to join a dynamic and innovative team and grow with a forward-thinking organization that is changing to course of medicine.

Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in an aspiring, caring and empowering environment with colleagues who are genuinely supportive regardless of location or seniority and collaborate as one team.

Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!

As the Central Risk Manager, Risk-Based Study Execution (RBx) you’ll have the opportunity to support the Department in the innovative implementation of Risk-Based Study Execution processes on all of Premier’s clinical studies. For this role, you’ll need to possess an established project and program management background, and have a working knowledge of different project management methodologies and disciplines along with experience in risk management on clinical or technical projects aligned with the latest industry regulations and guidance.

What you’ll be doing:

  • Support innovative, yet uniform implementation of Premier’s strategic vision for RBx process
  • Evaluate current practices and contribute to the development and implementation of the new or revised RBx policy and supporting systems and tools
  • Collect relevant Key Risk Indicators (KRIs) and other metrics to allow evaluation, control and reporting of the potential risks that may hinder the reputation, safety, security and financial prosperity of Premier Research
  • Deliver clear and concise training and familiarization of the RBx process, system and tools to ensure consistent adherence to the relevant regulations, guidance and our risk policy
  • Administratively support the department’s implementation of the RBx process strategy for effective best practices, procedures, tools and controls related to the uniform implementation of the RBx process
  • Review and maintain the Risk Log for awarded clinical studies based on the pertinent risks and ensure that mitigations are incorporated into the project plans; consistently update the Risk Log for ongoing studies where Remarque will be implemented to ensure standardization across all functional areas at Premier Research
  • Document risk identification, evaluate and manage to standardize the approach across all functional areas at Premier Research

You'll need this to be considered:

  • Minimum of a Bachelor’s degree required; biological or science-related field preferred, along with 5 years experience within the pharmaceutical industry, with Project Management responsibility for delivery of clinical trials within the CRO/service environment or equivalent experience in a study role; project management methodologies and disciplines
  • Proven experience and good understanding of risk based study management with at least 8 different studies in several different therapeutic areas; Remarque based system experience desirable
  • Knowledge of ICH / GCP regulations with specific understanding of ICH E6 (R2) as well as knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
  • Knowledge of web based communication tools for training and conferences, experience of public speaking and mentoring, as well as development and training/coaching programs with the ability to illustrate advanced knowledge and experience of risk management
  • Ability to motivate teams both local and virtual to achieve results and influence and inspire action through strong decision-making skills
  • Strong verbal and written communication, negotiation and customer service skills
  • Good analytical and decision making skills
  • Good organizational and time-management skills, able prioritize work to meet deadlines; ability to multitask and set priorities in a high-paced environment
  • Maintains a positive, results orientated work environment; team player, collaborative and able to support an effective team; accountable, dependable and strong commitment to quality and process