Sr. Central Risk Manager (Germany) - Sponsor-dedicated

Sr. Central Risk Manager (Germany) - Sponsor-dedicated

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

The Sr Central Risk Manager (CRM) serves as the subject matter expert for protocol execution risk management, risk-based monitoring (RBM) strategy and centralized monitoring within the project team. The Sr. 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. Performs all tasks routinely and independently. May provide support to other CRMs including training and mentoring. May review and approve RACTs.

JOB RESPONSIBILITIES
-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 cross-functional 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. Requires 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.

QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)
-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.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

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. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

The Sr Central Risk Manager (CRM) serves as the subject matter expert for protocol execution risk management, risk-based monitoring (RBM) strategy and centralized monitoring within the project team. The Sr. 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. Performs all tasks routinely and independently. May provide support to other CRMs including training and mentoring. May review and approve RACTs.