Senior Manager, Study Start Up

<p><b>When our values align, there's no limit to what we can achieve.</b><br/> <br/>At Parexel, we all share the same goal - to improve the world'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're committed to making a difference.</p><p></p><p></p><p><b><u><span>Key Accountabilities</span></u></b><u><span>:</span></u></p><p></p><p><b><span>Oversight of activities</span></b></p><ul><li><p>Accountable for advancing study start-up activities for outsourced trials by understanding the objectives and assisting in the review and approval of the plan for country and site activation. </p></li><li><p>Laser focus approach to oversight of startup activities within our CRO assigned programs. Working with the CRO partners to maintain timelines and successful execution.</p></li><li><p>Accountable for all matters related to CRO partners study start-up requirements and must be able to communicate issues effectively to CRO counterpart and colleagues (e.g., CTM) as required.</p></li><li><p>Adopting a unique start-up methodology to drive site activations through oversight of all activities, driving delivery and compliance across the assigned regions and CRO partners</p></li><li><p>Leads day to day project activities in the matrix, by working closely with the Clinical Trial Manager and CRO counterparts.</p></li><li><p>Oversees start up activities with one or more CRO partners at a program and/or study level</p></li><li><p>Acting as a Senior Manager with regional colleagues co-ordinate regional information to present based on oversight of regional colleagues (if required) depending on size of study/complexity.</p></li><li><p>Evaluate performance and solve acute challenges and monitor timelines and progress vs. plan</p></li><li><p>Specialist knowledge of start-up requirements &amp; activities in each country and region, country requirements, inner workings of a country/ regulatory landscape. </p></li><li><p>Works collaboratively with functional colleagues to ensure successful completion of study start up, fostering productive working relationships with other collaborators within Regulatory, Legal, Contracts and Clinical Operations</p></li><li><p>Reviews program or study specifics to define project scope, timelines, and deliverables from project initiation and maintains/monitors throughout</p></li><li><p>Reviews and approves start up plan(s) that clarify study specific tasks, general timelines, and processes related to overall study start up.</p></li><li><p>Liaise with other project team members to ensure cohesive and clear project performance and expectation</p></li></ul><p></p><p><b><span>Collaborative relationships</span></b></p><ul><li><p><span>Collaborates effectively with cross-functional teams, CRO partners, and regional colleagues to advance study start-up activities, oversee site activation processes, and ensure timely execution of clinical trials that align with project objectives and regulatory requirements across diverse global landscapes.</span></p></li></ul><p></p><p><b><u>Skills:</u></b></p><ul><li><p>Demonstrates ability to analyze complex situations, develop comprehensive plans, and oversee their execution across multiple partners and regions.</p></li><li><p>Excels in building and maintaining productive relationships with diverse teams and stakeholders, both internal and external.</p></li><li><p>Applies expertise to define scope, set timelines, monitor progress, and solve challenges in complex, multi-faceted projects.</p></li><li><p>Exhibits strong ability to lead in a matrix environment, communicate effectively at all levels, and present complex information to various stakeholders.</p></li></ul><p></p><p><b><u>Knowledge and Experience</u></b>:</p><ul><li><p>Extensive pharmaceutical or related industry experience</p></li><li><p>Extensive previous experience of working in a Start-up team, Clinical Trial Specialist, CRA, Clinical Trial Manager or similar having worked on global clinical trials. </p></li><li><p>Experience in project management, CRO experience, change management or process design are beneficial</p></li><li><p>The candidate must have a good working knowledge of clinical operations, clinical processes and medical terminology.</p></li><li><p>Excellent knowledge of GCP and regulations</p></li><li><p>Experience of controlled drug substances processed would be beneficial</p></li><li><p>Experience of developing junior members of staff would be beneficial</p></li><li><p>Experience of Regulatory Inspections</p></li></ul><p></p><p><b><u>Education:</u></b></p><ul><li><p>Degree (BSc) or equivalent experience gained through time in industry (&gt;5yrs)</p></li></ul><p></p><p></p>