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Director Clinical Operations

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Our Clinical Operations department is currently looking for a Director Clinical Operations (Full-time) to join our team.The Director Clinical Operations (DCO) is accountable for oversight of the Clinical Operations strategy and team, including Clinical Trial Managers, Clinical Trial Coordinators, Site Start-up Specialists, etc. The DCO will lead and design clinical operations initiatives across projects as well as managing the team, CROs and other clinical ; The DCO will provide strategic and technical leadership to ensure clinical trials are properly defined, planned and executed; drive engagement, development, retention and resourcing of the Clinical Operations team; provide expertise and consultation to project teams to facilitate problem resolution, successful outcomes and quality results, leading and ensuring the (global) clinical studies are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with the appropriate quality standards including GCP/ICH requirements and applicable international and local regulations. In addition the DCO will have a ‘Site Ambassador’ role. This role consists of the DCO being a direct & consistent cross-program point of contact and escalation point for any/all ProQR queries or concern from sites; the DCO will also have direct communication with sites and visit sites in person to maintain, enhance and promote good site relationships.Key Duties and delivery across programs, overseeing cross-functional alignment, budget, and timelines. Participate in program strategy meetings, contributing the operational strategy of responsible program/studies. Lead efforts for the selection and oversight of external service providers, including CROs and other vendors as necessary. Develop and manage clinical trial budgets, providing ongoing financial reporting and forecasting; oversees budgets and timelines for responsible program. Lead/participate in vendor/site budget negotiations and assists with Clinical Trial Agreements as necessary. Participate in request and review of scope of work, budgets, vendor performance and issue resolution. Coordinate cross functional efforts to achieve study objectives and goals. Identify and communicate study issues that will impact budget, resources and timelines. Provide support/escalation point for CO study team members as needed. Establish and maintain relationships with assigned investigator sites, vendors and consultants, through regular contact and personal visits as well as being a company escalation point. Evaluate and approve potential investigator site lists and assists with their inclusion in the study, ensuring proper prequalification of clinical sites. Participate in the preparation, review and finalization of clinical study-related documents such as protocols, protocol amendments, Clinical Study Reports (CSRs), regulatory submissions and documents, and other publications as required. Ensure documentation prepared internally or by CRO(s) is completed in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies/programs. Participate in the ongoing and final review of clinical study data to ensure the data is accurate and complete, and assessment of the impact of this data to the study and program. Mentor more junior team members. Lead and/or contribute to department initiatives, and assists in the design and implementation of standardized work processes. Develop positive and enduring relationships with current and potential study site staff by conducting site visits, act as the point of contact for escalations and actively participating in study/program meetings where site staff are present.Location: Leiden, NL or Cambridge, Massachusetts, US.We expect our Director Clinical Operations (DCO) to have: Minimum RN or Bachelor’s degree in a scientific discipline and at least ten (10) years’ experience in managing clinical trials. Ophthalmology experience will be an advantage. Experience working in Phase I through IV in a variety of different study types, vendors and geographies. Working knowledge of, and experience with, clinical trial design, conduct, data acquisition and reporting.Additionally:An understanding of and experience in the drug development process is required including: initiation procedures, clinical monitoring functions, drug safety reporting, data flow from external sites to internal processing/review/query resolution, data analysis and study report generation. Thorough knowledge of medical terminology, Good Clinical Practice, ICH guidelines and regulatory requirements. Able to recognize needs, find solutions and take initiative to address in a pro-active manner. Strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner. Demonstrated effective team leadership in cross-functional matrix teams. Strong organizational and time management skills. Excellent communication skills, both oral and written. Adjusts content and style for audience; effectively delivers key messages; able to manage and communicate with cross-functional teams and stake holders. Fluency in English. Expertise in Microsoft Word, PowerPoint, and Excel is required and experience with Microsoft Project. Experience with influencing and negotiating to achieve team delivery; flexible, proactive and solution-focused. Excellent Productivity/Organizing/Planning – Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously. Ability to proactively identify and take appropriate initiatives to fulfil the requirements of the role. Ability to maintain a high level of productivity with minimal supervision. Strong capability of strategic thinking and proposing innovative solutions to issues. High level of initiative and ability to work independently; self-motivated and achievement driven. Advanced competence in collaboration & teamwork, communications, influence, conflict resolution, strategic agility, planning & organizing, team building, driving results and problem insights. Strong research and analytical skills. Able to distill complex information from multiple sources and draw meaningful conclusions and insights.

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