Global Study Start-Up and Regulatory (Clinical Operations) Project ManagerOffice based in Central LondonAn exciting opportunity to join a rapidly growing CRO with a strong industry reputation for quality is seeking a Global Study Start-Up and Regulatory Project Manager to join the business on a permanent basis, with the chance to join a growing department and potentially take on some line management responsibilities in addition to core project management activities.Key Responsibilities:- Effectively direct and coordinate all aspects of global study start-up activities according to sponsor and project specifications.- Perform quality checks on submission documents and essential site documentation.- Lead a team of Study Start-Up Coordinators to ensure necessary approvals in place across different regions globally.- Prepare and approve informed consent forms.- Review pertinent regulations to develop proactive solutions to start-up issues and challenges.- Present during bid defences, audits and capabilities meetings.- Key point of contact for the sponsor regarding study start-up activities.- Potentially carry out line management activities for locally based Submissions Coordinators.Required Experience:- Previous experience of coordinating study start-up activities and regulatory submissions internationally (at least across European countries).- Previous hands-on experience of conducting ethics and local health authority submissions.- A minimum of a Bachelor's degree in a life science.- Must have prior experience in a similar position within a CRO, Biotech or Pharmaceutical Company.This position represents a great opportunity to join a growing organisation with a strong industry reputation and low staff turnover, with good prospects for career development due to this being an expanding team.If you are interested in exploring such a career move please forward your CV to Sam.Doherty@secpharma.com or call +44 (0) 207 255 6665 and ask for Sam Doherty.

Senior Clinical Trial Manager - Permanent Lausanne area with WFH flexibilityAn exciting opportunity with a growing Biotechnology company in the Lausanne region is currently seeking a Senior Clinical Trial Manager on a permanent basis, a role initially aligned to early development but which will work predominantly within oncology to provide cross-functional leadership and have the opportunity to contribute to activities more associated with clinical science (i.e. protocol design/development).Key Responsibilities: - Accountable for the leadership and oversight of multiple (likely 2) global clinical trials within oncology and anti-infectives across all stages of the drug development process (Phase I-III). - Ensure completion of studies undertaken in accordance with timelines, study plans, quality, resources and budget. - Ultimate oversight and participate in the selection of external vendors (CRO's, independent consultants and other vendors) to ensure delivery against agreed scope of work. - Oversight of the global study management team and all functions involved in study (clinical site management, biometrics, regulatory, central labs etc).- Responsible for study finances across region/countries assigned as part of company-sponsored post-marketing studies, in addition to grants for investigator initiated studies. - Support the local organisation in achieving and delivering the organisation's local and regional medical strategy. - Ensure that Clinical Trial Management System is updated as necessary. The Ideal Candidate Will Have: - Must hold a life science or medical-related degree or equivalent qualification. - Previous clinical trial management experience in a CRO, Biotech or Pharmaceutical Company within the Oncology TA, though other complex areas (rare diseases, neuroscience, infectious diseases) would be sought after.- Experience in clinical trial planning and conduct. - Thorough knowledge of ICH-GCP and applicable local/regional regulations. - Experience of leading global Phase II-III clinical trials, with experience in managing trials with an adaptive design a definite advantage.Overall this vacancy represents a fantastic opportunity to join a Biotech with an exciting pipeline on a permanent basis, with the perfect platform to develop and enhance your career in the long term in an innovative and forward-thinking environment. There is also a highly competitive remunerations package available for the right candidate. If you would like to apply for this position, please forward your CV to Sam.Doherty@secpharma.com or call Sam Doherty on +44 (0) 207 255 6665 for more information.

Global Clinical Trial Leader - Permanent Office Based, West London or Home BasedA leading biopharmaceutical company with a comprehensive pipeline within oncology comprising close to 20 molecules of various modalities and aligned to both solid tumour indications and haematological malignancies is seeking a Global Clinical Trial Leader to join their rapidly growing late stage oncology development team on a permanent basis.Key Responsibilities: - Accountable for the leadership and oversight of multiple global clinical trials/programmes across all stages of the drug development process (Phase I-III). - Ensure completion of studies undertaken in accordance with timelines, study plans, quality, resources and budget. - Ultimate oversight and participate in the selection of external vendors (CRO's, independent consultants and other vendors) to ensure delivery against agreed scope of work. - Oversight of the global study management team and all functions involved in study (clinical site management, biometrics, regulatory, central labs etc). - Responsible for study finances across region/countries assigned as part of company-sponsored post-marketing studies, in addition to grants for investigator initiated studies. - Support the local organisation in achieving and delivering the organisation's local and regional medical strategy. - Ensure that Clinical Trial Management System is updated as necessary. The Ideal Candidate Will Have: - Must hold a life science or medical-related degree or equivalent qualification. - Previous clinical trial management experience in a CRO, Biotech or Pharmaceutical Company. - Experience in clinical trial planning and conduct. - Thorough knowledge of ICH-GCP and applicable local/regional regulations. - Experience of leading global Phase II-III clinical trials, with experience in oncology or adaptive/innovative trial design.Overall this vacancy represents a fantastic opportunity to join a prestigious organisation known for innovation, and a late stage oncology department which has a demonstrable history of enabling career progression towards programme leadership, with the chance to work in a fast-paced and rewarding environment.If you would like to apply for this position, please forward your CV to Sam.Doherty@secpharma.com or call Sam Doherty on +44 (0) 207 255 6665 for more information.