Dir Global Site & Study Operations

<h2><b>Career Category</b></h2>Clinical<h2></h2><h2><b>Job Description</b></h2><p><u><b>Accountabilities</b></u></p><div><span><span>•</span></span><span>The Country Study and Site Operations Head is accountable to drive all country and hub &amp; spoke execution and quality measures, including study operations, site operations, and site engagement, while ensuring operational capabilities support the delivery of the geographic portfolio with high-quality data in compliance with local regulations.</span></div><div><span><span>•</span></span><span>Ensure study execution aligns with global strategies across trials and act as a key advisor for country commitments.</span></div><div><span><span>•</span></span><span>Provide leadership and line management to the Country/Hub team, offering clear guidance, fostering capability development, and driving portfolio objectives.</span></div><div><span><span>•</span></span><span>Represent the country strategically in organizational </span><span>initiatives at all levels.</span></div><div><span><span>•</span></span><span>Lead the Country Management Team (CMT).</span></div><div><span><span>•</span></span><span>Ensure adequate resourcing </span></div><p></p><p><u><b>Responsibilities</b></u></p><div><span><span>•</span></span><span>Accountable for all study execution in assigned geography and quality metrics including delivering study start-up, patient enrollment, retention trends, and data flow metrics in alignment with global strategies across trials, serving as key advisor for country commitments</span></div><div><span><span>•</span></span><span>Oversee clinical study budgets and forecasting to ensure efficient use of resources and financial accountability.</span></div><div><span><span>•</span></span><span>Build, lead, and develop the Country/Hub team to effectively manage resources, ensuring appropriately skilled and high-performing staff to deliver the portfolio and meet organizational deliverables.</span></div><div><span><span>•</span></span><span>Drive country site engagement by leading SEL AD and/or SELs, aligning with global strategy, ensuring compliance, strengthening partnerships, and securing Partner-of-Choice positioning through innovation and leadership collaboration.”</span></div><div><span><span>•</span></span><span>Shape and foster collaboration between local functional teams and global study teams to drive delivery of study portfolio in assigned geography</span></div><div><span><span>•</span></span><span>Partner with internal stakeholders to monitor study progress and drive local actions plan &amp; issue resolution, and aggregates country progress and challenges for senior management</span></div><div><span><span>•</span></span><span>Represent country in governance meetings, communicating cross-study progress to region / CPSO</span></div><div><span><span>•</span></span><span>Advocate for study placement in considerations of strengths and growth opportunities of assigned geography</span></div><div><span><span>•</span></span><span>Lead internal and external meetings to ensure delivery on portfolio targets</span></div><div><span><span>•</span></span><span>Key advisor for site selection, and identifies &amp; communicates priority sites, allocating resources as required</span></div><div><span><span>•</span></span><span>Point of escalation to support resolution of country-wide issues including risks which impact delivery or quality of clinical trials and/ patient safety</span></div><div><span><span>•</span></span><span>Lead country-level risk assessments and implement mitigation strategies to ensure patient safety, compliance, and trial continuity</span></div><div><span><span>•</span></span><span>Oversees vendor selection, setup, performance oversight across local roles (study delivery, monitoring) in alignment with budget considerations and serves as point-of-escalation</span></div><div><span><span>•</span></span><span>Promote continuous improvement and best practice sharing to enhance operational efficiency and site engagement.</span></div><div><span><span>•</span></span><span>Build and develop strong local leadership and study teams to deliver on portfolio goals and support long-term organizational capability</span></div><div><span><span>•</span></span><span>Ensures adherence to key requirements (e.g., ICH-GCP, SOP, country regulations), study inspection readiness, internal audits and CAPA processes</span></div><div><span><span>•</span></span><span>Work with SDRM to ensure timely and adequately resourcing for all roles </span></div><p></p><p><u><b>Authority</b></u><span>​</span></p><div><span><span>•</span></span><span>Country level oversight and delivery of clinical trials in alignment with Global Study Strategy</span></div><div><span><span>•</span></span><span>Authority over Country/Hub level trial operations, site monitoring, risk management, resource allocation and stakeholder coordination</span></div><div><span><span>•</span></span><span>Lead the country site engagement strategy by guiding SEL AD and/or SELs to maintain compliance, foster strong partnerships, and achieve Partner-of-Choice status.</span></div><p></p><p><u><b>Outputs</b></u></p><div><span><span>•</span></span><span>Trial delivery and optimization of all global and local studies run within the country</span></div><div><span><span>•</span></span><span>Consistent quality in trial operations across studies in country</span></div><div><span><span>•</span></span><span>Effective leadership and development of a high-performing country team.</span></div><div><span><span>•</span></span><span>Strong strategic representation of country in global and regional initiatives and stakeholder engagements</span></div><p></p><p><u><b>Competencies</b></u></p><div><span><span>•</span></span><span>Understanding of global/local level regulations and compliance for clinical execution, including concepts related to ethics submissions, study start-up processes, and site inspection readiness at global/regional level</span></div><div><span><span>•</span></span><span>Big picture, pro-active thinking with the ability to assess broad impacts across multiple product portfolios to identify innovative solutions</span></div><div><span><span>•</span></span><span>Experience in assessing internal capabilities and identifying key capabilities to build training content, monitoring skill improvement, and drive competency builds across function and within teams</span></div><div><span><span>•</span></span><span>Experience in delivering portfolio/cross-study level, budgets, timelines, and performance metrics (time, cost, quality) aligned to country/global / functional priorities.</span></div><div><span><span>•</span></span><span>Drive risk-based quality management adoption and understanding across organization</span></div><div><span><span>•</span></span><span>Leading expertise in country/global clinical trial processes, operations with strong track record of program delivery​ across a country/regional/global portfolio</span></div><div><span><span>•</span></span><span>Experience driving and leading organizations through​ cross-functional change initiatives such as identifying solutions to problems and innovating and change strategies and structure to meet future needs</span></div><div><span><span>•</span></span><span>Adept in intra country and/or cross geography, cultural dynamics and running efficient virtual country/global teams - Ability to lead and motivate geographically dispersed teams in an inclusive manner</span></div><div><span><span>•</span></span><span>Understand country regional trends/global impacting patient enrollment and patient safety compliance</span></div><div><span><span>•</span></span><span>Experience in<span>  </span>assessing internal capabilities and identifying key capabilities to build training content, monitoring skill improvement, and drive competency builds across function and within teams</span></div><div><span><span>•</span></span><span>Proficient in driving and leading continuous improvement initiatives for team&#39;s working practices, ensuring cross-functional adoption of new processes</span></div><div></div><p><b>Minimum Requirements</b></p><div><span><span>•</span></span><span>Doctorate degree and 4<span>  </span>years of clinical execution experience OR</span></div><div><span><span>•</span></span><span>Master’s degree and 8<span>  </span>years of clinical execution experience OR</span></div><div><span><span>•</span></span><span>Bachelor’s degree and 10<span>  </span>years of<span>  </span>clinical execution experience</span></div><div><span><span>•</span></span><span>In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.<span>  </span>Your managerial experience may run concurrently with the required technical experience referenced above</span></div><div></div><p><b>Preferred Requirements </b></p><div><span><span>•</span></span><span>&#43;10 years work experience in life sciences or medically related field, including 8 years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)</span></div><div><span><span>•</span></span><span>Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)</span></div><div><span><span>•</span></span><span>Significant experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials</span></div><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.