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Central Risk Manager

Waterloo, Merseyside, United Kingdom, £ £ - Annual Annual, Permanent

Description:

Central Risk Manager

Reports to: Associate Director, Central Monitoring; or designee

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Here at Syneos Health we are currently recruiting for a Central Risk Manager.

*Job Details*
The Central Risk Manager I (CRM I) serves as the subject matter expert for protocol execution risk
management, risk-based monitoring (RBM) strategy and centralized monitoring within the project team.
The CRM is accountable for drafting the initial RBM strategy, working with the cross-functional teams to
assess protocol execution risks and adapt the cross-functional RBM strategy.

Responsibilities for this role are as follows:

* Provides advice and subject matter expertise for the development of the monitoring strategy required for the project and where required, advises the project team on any updates to the monitoring strategy during the study based on risks.
* Works with cross-functional leads to understand complex indications and risks and seeks input on risk mitigations. Provides guidance to cross-functional leads to ensure consistency within programs, therapeutic areas and/or sponsors.
* Drafts initial risk assessment, supports the project team in ensuring cross-functional involvement in the finalization of the RACT.
* Ensures PL transfers risks identified to the correct tracking system and supports ongoing crossfunctional review of risks throughout the project.
* Provides advice on the development of functional plans to ensure identified risks are mitigated.
* Assess tools where available to conduct remote data review and centralized statistical monitoring, identifying risks to data quality and integrity.
* Facilitates review of findings with the internal cross- functional team and sponsor. Require support from cross-functional leads on complex risks and mitigations.
* With support and where required, collaborates with other team members and Sponsor to identify Quality Tolerance Limits.
* As required, provides development and delivery of initial and ongoing training to the study team regarding the risk assessment, centralized monitoring and the wider risk-based monitoring strategy.
* Coaches and mentors peers regarding functional delivery, evaluation of project risks, and action implementation.
* Collaborates with other functional areas to ensure risks identified in compliance and delivery according to protocol, ICH/GCP and/or Good Pharmacoepidemiology Practices (GPP) and country regulations, including medical monitoring, Safety, Quality Assurance (QA). Ensures Inspection Readiness for risk assessment and centralized monitoring scope.
* Understands the study scope of work, budget and protocol content for their assigned study.
* Escalates to the PM any risk assessment and centralized monitoring deliverables (timeline, quality, and budget) at risk, and any activities and requests which are out of contracted scope.
* May participate in business development activities including monitoring strategy and budget input, defines meetings and proposal development.
The ideal candidate will need the following experience / skills to be considered:

* 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.

* Expert in Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements.

* Expert in Risk-Based Monitoring Strategies processes and tools preferred.

* Expert in Integrated Quality Risk Management (IQRM) theories.

* Must demonstrate good computer skills and be able to embrace new technologies.

* Mastery of MS Excel (sorting, filtering, calculating, pivoting).

* Mastery of Analytical Data Visualization Tools (adjusting visualizations, selecting subsets of data to analyze, identification of trends and outliers).

* Knowledge of statistical analysis techniques, visualizations and tools (Cluepoints, Medidata-CSA, Hy's Law, Funnel Plots, Box and Whiskers).

* Knowledge of Lean Six Sigma, RACT tools.

* Strong analytical skills and well-developed understanding of statistical concepts.

* Well-developed therapeutic expertise.

* Excellent verbal and written communication skills.

* Strong negotiation skills, organizational skills and problem-solving skills.

* Demonstrated strong leadership, tactical and strategic thinking skills.

* Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner.

* Knowledge of financial concepts as related to forecasting, budgeting, and proposal generation.

* Demonstrate understanding of the workflow process, roles and responsibilities of multiple functional areas, and ability to work across those functional areas.

* Ability to understand, explain and communicate project concepts and put into detailed plans.

* Ability to teach, train and mentor employees of all levels to achieve project, departmental, personal and organizational goals.

* Requires above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. This includes excellent communication and presentation skills, both written and spoken, with an ability to inform, influence, convince, and persuade.

*

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its

sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents

may differ from those listed in the Job Description. The Company, at its sole discretion, will determine

what constitutes as equivalent to the qualifications described above. Further, nothing contained herein

should be construed to create an employment contract. Occasionally, required skills/experiences for jobs

are expressed in brief terms. Any language contained herein is intended to fully comply with all

obligations imposed by the legislation of each country in which it operates, including the implementation

of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Job Details

1219072343
Sun, 16 May 2021 19:00:00 EST
Not Specified
Waterloo, Merseyside, United Kingdom
Permanent
£ £ - Annual Annual