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Head of Clinical Operations (m/w/d) (DE)
Abteilungsleiter, Clinical, Clinical Operations, Pharma, Top 100 CISA
Job Purpose (summarise the primary purpose of the job): To proactively and effectively lead and champion the preparation and execution of clinical operations of clinical trials underpinning the XXX Therapeutics (XT) R&D programme. To translate XTs clinical study strategy to operational objectives and a delivery plan. To lead the clinical operations team to deliver XT clinical trials on schedule and within agreed budget. To perform this role successfully the incumbent must be able to perform each generic and job specific responsibility listed below satisfactorily Supervisory Responsibility: Management of the Global Clinical Operations team with a combination of senior clinical operations staff, study managers, in-house CRA’s and clinical trial assistants working from various locations. Generic Responsibilities: · To comply with all regulations as instructed by management or as per the ICH-GCP Guideline. · To carry out all duties whilst maintaining good Health & Safety practice with due care to yourself and others. · To control and maintain your personal training folder. · To comply with all Company policies and procedures. · To carry out any other reasonable request as directed by your Manager or another member of the Management team. · To follow a code of conduct conducive to a professional environment. Job Specific Responsibilities: · To carry out all tasks as directed by Management. · To partake in the Performance Management system process as directed by management. General · Accountable for all the operational aspects of clinical studies run by XT for phase I to phase III. · Accountable for the costs, the quality and timelines for all clinical studies. · Accountable to the Clinical Director for the development of innovative and benchmarked Clinical Operations processes to match the evolving clinical operations needs of XT. · Support the review and implementation of global clinical development plans and provide guidance on the operational clinical study strategy. · Review of scientific publications and clinical modules of eCTD. Management of Global Clinical Operations Team · Accountable for the establishment of a single Clinical Operations team across the international XTL sites with common SOPs, common document archiving and common training programmes. · Provide line management, direction, motivation and career development for the global clinical operational team. · Accountable for resource planning across all clinical operations making effective use of the combination of all individuals experience and knowledge whilst also being respectful of the budget. Compliance · Accountable for the GCP compliance of the Clinical Operation team and maintenance of archived documents to be ready for Competent Authorities inspection. Reporting and Integration · Operate as the ‘right hand’ of the Clinical Director for all operational aspects of XT clinical trials. · Accountable to the Clinical Director for the provision of input of Clinical Operations team to Project Management, Maintenance and Monthly reporting of project accounts, Monthly report on clinical studies, and Monthly reports on the risk maps. · Accountability to customers in Supply Operations, Distribution and Quality, Regulatory Affairs, Pharmacovigilance and Project Management in providing timely information on trial scope, material requirements and investigations relating to maintaining GCP. · Provide feasibility evaluation for clinical trial opportunities as they arise. · Cooperate with local Medical Affairs and/or Marketing on local investigator involvement in clinical studies. · To ensure that Clinical Operations works efficiently with the Clinical Science and Clinical Development groups within the Clinical Department, and other departments where needed (e.g. QA, Regulatory Affairs) in the preparation of clinical trials and supporting documentation (e.g. contracting, vendor qualification, (N)IMP supply, ICF preparation, endpoint questionnaire, study plans etc.). · To ensure that Clinical Operations works closely with the Project Management team, in order to secure continuous effective planning, internal & external benchmarking of execution and compliance with XT financial plans. Key Performance Indicators: · To integrate the teams in clinical operations and ensure an efficient line management and project structure globally, to select staff for studies, manage training and mentoring of new employees whilst ensuring the highest levels of practice and compliance. Working with the Clinical Director to build the staffing necessary for the studies. · To develop business cases and/or present to the Executive Team and/or Board to propose any major changes in Clinical Operations and/or applicable processes (e.g. major expansion or diminishing of the Clinical Operations group). · To keep the study budget within the approved financial budget and ensure a transparent and efficient change order process. · To work with Project Managers and the R&D Finance staff to establish accurate recording of study projects spending, preparation of Cost Approval Forms (CAFs) which will be reported monthly to the Executive Team and/or Board. · Efficient implementation of changes and/or new procedures/IT applications in the Clinical Operations group (e.g. eTMF). Qualifications/Experience required: · Relevant degree in life sciences · At least 8 years’ experience in managing a Clinical Development and or /clinical operations programme within Biotech or Pharma · At least 3 years of experience in a senior clinical study manager role · At least 4 years of relevant line management experience of a Clinical Operations group or department · Knowledge of ICH-GCP, clinical trial process, other relevant Guidance documents (e.g. ICH, FDA, EMEA), and of regulations and requirements for clinical trials · Experience with implementing improvements in Clinical Operations processes · Experience with oversight of multiple clinical studies running simultaneously · Demonstrated experience in efficiently collaborating with other departments and functions · Knowledge and understanding of best practice of clinical operations · Experience with setting-up and/or reviewing Standard Operations Procedures Personal Competencies required: · Ability to manage and lead a team to ensure the needs of the business are met · Excellent communication/interpersonal skills and ability to mentor and develop others · Willing to take on and build efficient business processes, able to identify risks and implement mitigation strategies · Articulate in written and oral English. Other languages desirable but not essential. · Efficiency in problem solving · Experience working in a global organisation and team building · Ability to efficiently prioritize and plan activities to deliver within timelines and budgets · Excellent customer service skills · Experience with arranging and presenting to Key Opinion Leader and/or Investigators and professional network building · Ability to make good judgements and sound business decisions · Provide options to advance the business in novel and profitable direction · Proven ability to work in a rapidly changing environment · Excellent organisational and planning skills