· Manages overall operation of clinical studies or clinical projects including project planning, budget, resource management, site management and contract research organization management within the overall context of an approved clinical operational plan.
· Responsible for managing full scope of study (ies), including protocol, conduct of study, data collection, timely patient enrollment and completion of study report.
· Develops study-related documents and assure compliance with good clinical practices and regulatory guidelines. Recommends and implements innovative process ideas to impact clinical trials management.
· Acts as a cross functional liaison to ensure study plan aligns with business development strategies
• Ensure that all clinical studies comply with the clinical protocol, relevant Standard Operating Procedures (SOPs), the most recent ICH requirements for Good Clinical Practice (GCP) and other applicable regulations
• Evaluate and select contractors (CROs, SMOs, central laboratories, contract monitors etc.) in accordance with the Company's SOPs
• Define the scope of work to be contracted out and agree to the roles and responsibilities of each party involved in the study
• Provide input into CRO and other clinical study agreements and assist in the negotiation of these agreements
• Supervise outsourced tasks and services and manage contractor relationships
• Provide guidance to the clinical project team and the CRO to ensure that the objectives of the clinical study are me
• Assist in the preparation of the clinical study budget and manage clinical study to approved budget
• Ensure that adverse events (AEs) from clinical studies undertaken are reported in accordance with the Company's procedures and to satisfy ethical and regulatory requirements
• Participate in the identification, selection and management of clinical study sites
• Ensure that regulatory documents are obtained from study sites and that study and site files are set up and maintained in accordance with GCP and relevant SOPs
• Ensure CROs and clinical sites are ready for inspection where appropriate
• Co-monitor clinical study sites with the external monitor where necessary
• Oversee and assist in the preparation, review and approval of clinical study documents (e.g. agreements, protocols, informed consent forms (ICFs), case report forms (CRFs), lnvestigational Medicinal Product (IMP) labelling, sections of investigational drug brochures and study reports)
• Co-ordinate the distribution of clinical study supplies to contractor or sites
• Participate in project meetings and provide status reports and timelines for the critical aspects of the project plan
• Participate in planning and presenting at investigator meetings
• Ensure that regulatory and ethical approval is obtained for all clinical studies prior to site initiation
• Ensure that clinical trial insurance is obtained for all clinical studies prior to site initiation
• Ensure that new clinical studies are added to the appropriate study registries
• Assist with the interim and final reporting and data analysis of clinical results
• Provide input into the planning, timelines and costing of new clinical studies
• Assist with preparation and/or review of SOPs for clinical research
• Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BTG values
• Complete additional tasks considered necessary to meet business and customer requirements as indicated by the Line Manager
The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.
• Accountable to - Director, Clinical Operations
• Internal - Colleagues and peers in other departments including Regulatory, Operations, Medical Affairs, Biostatistics, Quality, Project management, Finance, Marketing
• External- Investigators, CRAs, vendor organizations, consultants, auditors
Education and Experience
• BA/BSc degree in life sciences or health related discipline (post-graduate degree preferred)
• Extensive relevant experience in clinical development organization, managing global clinical studies in the CRO/pharmaceutical industry, preferably including Phases I-IV.
• Understanding of the drug development process, ideally to include participating in regulatory submissions.
• Working knowledge of GCP/ICH guidelines and FDA/EMEA regulations
• Experience working in a matrix environment, ideally across countries
• Experience with forecasting and budgeting
Skills and Attributes
· Ability to effectively manage/prioritise multiple priorities
· Problem solving ability with the tenacity to drive projects to conclusion
· Excellent organisational skills, attention to detail, commitment to quality and the ability to work independently
· Proficiency in Microsoft Office software (PowerPoint, Word, Excel, Project)
- Excellent oral and written communication skills
- Excellent interpersonal skills
- Ability to travel domestically and internationally