• Lead operational contact for clinical studies • Provide strategic and operational leadership to the clinical operations team • Ensure project milestones delivery on time, within budget, high quality, and in compliance • Responsible for all operational aspects, strategic input, and progress of clinical trial • Manage vendor activities to support clinical studies • Oversee study timelines and budget planning • Participate in country and site feasibility/selection process • Ensure studies are 'inspection ready' at all times • Create and foster strong strategic partnerships with colleagues

• Develop and implement clinical operations strategies to support the company's product pipeline, ensuring alignment with corporate goals and objectives • Lead and oversee the strategic planning, implementation and execution of clinical trials in accordance with project timelines, budget, and quality standards • Develop and manage comprehensive site management plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies • Collaborate cross functionally with internal teams to ensure the alignment on clinical trial objectives and milestones and the successful execution and monitoring of clinical trials • Serve as the point of contact for CROs and vendors, overseeing their site management performance and ensuring adherence to contractual agreements, timelines and quality standards • Track accrued site operations and monitoring expenditure against the actual budget for each program • Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct • Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity • In collaboration with the Head of Clinical Operations, hire, train, develop, and mentor the Clinical Operations/Clinical Research Associate team, fostering a culture of collaboration, accountability, continues improvement, and operational excellence • Identify and solve problems that may arise during the trial • Continuously evaluate and improve clinical trial processes

Title: Senior Clinical Operations Manager - Sydney, New South Wales, Australia - Melbourne, Victoria, Australia - Adelaide, South Australia, Australia - Brisbane, Queensland, Australia Full time Remote We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As a Senior Clinical Operations Manager, you will oversee, train, resource, coach and performance manage a team of CRA’s. You will focus on end results using metrics and key performance indicators to lead performance. You will act as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. You will also work in collaboration with the leadership team for resourcing needs. What You’ll Do: - Manages staff, providing coaching, mentorship and work direction. - Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews, recruits and selects staff. - Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company. - Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. Ensures timeliness and accuracy of timesheets and expense reports. - Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects. Raises appropriately any issues which may impact project deliverables at a country level. - Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate. - Assures adherence to good ethical and regulatory standards. - Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required. - Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status. - Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable. - Participates in process improvement/development initiatives. - Ensures understanding and facilitation of the risk-based monitoring approach. - May provide input into bids and contribute to the procurement of new business where required. - Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. - May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company. Education and Experience Requirements: - Minimum of 3+ years of managing CRA’s. - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: - Advanced mentoring/leadership/supervisory skills - Excellent clinical trials monitoring skills; Remote and on-site - Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines) - Demonstrated ability to evaluate medical research data - Strong organizational and negotiation skills - Strong attention to detail - Advanced written and oral communication skills - Good knowledge of English language and grammar - Demonstrated use of computer to include data entry, archival and retrieval - Ability to travel as needed - Excellent teammate with team building skills - Excellent interpersonal and conflict resolution skills - Advanced ability to utilize problem-solving techniques applicable to constantly changing environment - Solid knowledge of medical/therapeutic areas and medical terminology Benefits Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer. - Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues. - Flexibility: Balance your work and personal life with flexible arrangements. - Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave. - Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you. - Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.

• Plan, direct, coordinate, and deliver activities for designated clinical-study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. • Manage regional trials (moderate complexity) and/or act in a supportive role in managing complex global trials. • Serve as primary point-of-contact and primary escalation point to the client. • Coordinate and oversee all functional services including external vendors to the established timeline and budget. • Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. • Ensure functional areas are fully aware of the study scope and are managing the scope for their functional areas accordingly. • Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation. • Ensure Quality management for assigned projects, including eTMF Inspection readiness. • Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise. • Lead both internal and client meetings and set expectations for the project team. • Communicate effectively with client and Precision management to relay protocol/study issues and implements necessary actions in response to those issues.