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

Sr. Central Risk Manager (Germany) - Sponsor-dedicated<p></p><p>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.  </p><p>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.</p><p></p><p>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.</p><p></p><p>Discover what our 29,000 employees, across 110 countries already know: </p><p></p><p><b>WORK HERE MATTERS EVERYWHERE</b></p><p></p><p>Why Syneos Health</p><ul><li>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.</li><li>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. </li><li>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. </li></ul><p></p><p><b>Job Responsibilities</b></p><p></p><p>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.</p><p></p><p>JOB RESPONSIBILITIES<br/>-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.</p><p>-Works with cross-functional leads to understand complex indications and risks and seeks input on risk mitigations.<br/>-Provides guidance to cross-functional leads to ensure consistency within programs, therapeutic areas and/or sponsors.<br/>-Drafts initial risk assessment, supports the project team in ensuring cross-functional involvement in the finalization of the RACT.<br/>-Ensures PL transfers risks identified to the correct tracking system and supports ongoing cross-functional review of risks throughout the project.<br/>-Provides advice on the development of functional plans to ensure identified risks are mitigated.<br/>-Assess tools where available to conduct remote data review and centralized statistical monitoring, identifying risks to data quality and integrity.<br/>-Facilitates review of findings with the internal cross- functional team and sponsor. Requires support from cross-functional leads on complex risks and mitigations.<br/>-With support and where required, collaborates with other team members and Sponsor to identify Quality Tolerance Limits.<br/>-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.</p><p>-Coaches and mentors peers regarding functional delivery, evaluation of project risks, and action implementation.<br/>-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<br/>Readiness for risk assessment and centralized monitoring scope.<br/>-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.</p><p>-May participate in business development activities including monitoring strategy and budget input, defines meetings and proposal development.</p><p></p><p>QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)<br/>-Bachelor’s degree or RN in a related field or equivalent combination of educat