Clinical Operations Manager-FSP

<p><b>When our values align, there&#39;s no limit to what we can achieve.</b><br /> <br />At Parexel, we all share the same goal - to improve the world&#39;s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.</p><p>Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we&#39;re committed to making a difference.</p><p></p><p></p><p>Parexel has an exciting opportunity for a Clinical Operations Manager (Finance)! This is a hybrid role in Canada.</p><p></p><p><b>Job Purpose:</b><br />The Clinical Operations Manager (COM)/Clinical Operations Manager Finance (COM-F)/ Clinical Operations Manager Regulatory (COM-R) is responsible for the following:<br />• Performance and compliance for assigned protocols in a country in compliance with International Council for Harmonization (ICH) / Good Clinical Practice (GCP) and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.<br />• Budget/finance aspects, for execution and oversight of clinical trial country submissions and<br />approvals and to ensure Site Ready under the oversight of the Senior Clinical Operations Manager (SCOM) or Clinical Research Director (CRD).</p><p><br />This position has significant impact on the delivery of country specific trial commitments and objectives especially during study start-up.</p><p></p><p><b>Key Accountabilities:</b><br /><u>Study Management </u><br />• Manages country deliverables, timelines, and results for assigned protocols<br />to meet country commitments including quality and compliance in assigned<br />protocols in country<br />• Oversees Clinical Trial Coordinators as applicable<br />• Coordinates and liaises with Clinical Research Managers (CRMs), Clinical<br />Research Associates (CRAs) and Clinical Trial Coordinators (CTCs),<br />Finance and Legal if appropriate to ensure country deliverables are obtained<br />for submissions, budgets, Clinical Trial Research Agreements (CTRAs) and<br />local milestones<br />• Collaborates closely with Headquarter to align country timelines for assigned<br />protocols<br />• Provides support and oversight to local vendors as applicable</p><p>Oversees and coordinates local processes, clinical and ancillary supplies,<br />import and export requirements, supplies destruction, local electronic/hard<br />copy filing, archiving and retention requirements, and insurance process<br />management. Enters and updates country information in clinical and finance<br />systems<br />• Delivers clinical and financial contracts within fair market value through<br />continual interaction with local clinical teams<br />• Works in partnership internally with Global Clinical Trial Organization<br />(GCTO) country operations, finance, regulatory affairs, pharmacovigilance,<br />legal and regional operations, Headquarter (HQ) functional areas and<br />externally with vendors and sites, Internal Review Board (IRB) / Independent<br />Ethics Committee (IEC) and Regulatory Authorities in submission and<br />approval related interactions</p><p><br /><b>Finance Management (as applicable)</b><br />• Has ownership of country and site budgets including development,<br />negotiation, and completion of Clinical Trial Research Agreements (CTRA)<br />• Oversees and tracks clinical research-related payments and payment<br />reconciliation at study close-out<br />• Oversees Foreign Corrupt Practices Act (FCPA), Denied Party<br />Screening/Office of Foreign Assets Control (DPS/OFAC) and maintenance<br />of financial systems and financial forecasting in conjunction with Senior<br />Clinical Operations Manager, Clinical Research Director and other roles<br />• Influences investigators, external partners, and country operations to adhere<br />to budget targets and agreed payment timelines</p><p><br /><b>Regulatory Management (as applicable)</b><br />• Executes and oversees clinical trial country submissions and approvals for<br />assigned protocols<br />• Develops local language materials including local language Informed<br />Consents and translations<br />• Interacts with IRB/ IEC and Regulatory Authority for assigned protocols</p><p><br /><b>Team development and support</b><br />• Contributes or leads initiatives and projects adding value to the business.<br />• Contributes strongly to the Clinical Operations Manager team and other<br />Country Operations roles knowledge by acting as process Subject Matter<br />Expert (SME), sharing best practices, making recommendations for<br />continuous improvement and providing training as appropriate/required.<br />• Contributes to Clinical Operations Manager team knowledge by acting as a<br />buddy/mentor and sharing best practices as appropriate/required</p><p><br /><b>Compliance with Parexel standards</b><br />• Complies with required training curriculum<br />• Completes timesheets accurately as required<br />• Submits expense reports as required<br />• Updates CV as required<br />• Maintain a working knowledge of and comply with Parexel processes, ICH-<br />GCPs and other applicable requirements</p><p><br /><b>Skills:</b><br />• Strong coordination and organizational skills.<br />• Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up<br />• Ability to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from the SCOM or manager<br />• Ability to make decisions independently with limited oversight from SCOM or manager.<br />• Requires a strong understanding of local regulatory environment<br />• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally<br />• Ability to lead a team of CTCs as applicable<br />• Problem solving is essential. Requires ability to proactively identify issues and risks, analyze root cause and propose solutions and escalate to management as applicable.</p><p><br /><u>Examples include:</u><br />Issues in budget/CTRA negotiation<br />o Quality and compliances issues<br />o Regulatory and legal issues<br />o Issues related to functional area deliverables that could jeopardize protocol milestones<br />• Effective and efficient time management, organizational and interpersonal<br />skills, and conflict management skills<br />• High sense of accountability and urgency to prioritize deliverables<br />• Strong communication, leadership, and negotiation skills as well as excellent influencing and training/ mentoring skills<br />• Ability to focus on multiple deliverables and protocols simultaneously<br />• Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people</p><ul><li>Positive mindset, growth mindset, capable of working independently and self – driven.</li><li>Ability to directly influence site staff</li><li>Excellent verbal and written influencing and training/mentoring skills, in local language and English</li><li>Minimal travel required.</li></ul><p>#LI-KW1</p>