StellenbeschreibungppOur client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world. /ppWe are currently looking for a: /ppbClinical Research Lead /bfor a b1 year contract, with the possibility of extension /bin Basel. /ph3JOB PURPOSE /h3pStudy Leader and/or Clinical Scientist for predominantly medium to high complexity, global studies and may provide additional Clinical Sciences support to high priority, high complexity, global studies. /ph3MAJOR ACCOUNTABILITIES RESPONSIBILITIES: /h3ulliLead the clinical protocol development process in collaboration with the Medical Lead and other line functions; responsible author for clinical protocols, amendments, etc.; contribute to the medical/scientific input given for the development of study-related documents and processes which resides in other line functions; contribute to the development of clinical sections of study-level regulatory documents. /liliLead development of strategic and scientific input into study concept, feasibility, and ability to execute; develops and implements study-level operational execution plan in partnership with key cross functional partners, if applicable. /liliCollaborate with key cross functional partners to identify and select strategic and high performing sites to ensure recruitment commitments are met. /liliLead a global cross functional CTT to ensure all trial deliverables are met; sets stretch goals, promotes realistic planning and timelines, and presents actionable alternatives to accelerate timelines. /liliPartner with line functions to gain input and alignment and manages internal and external stakeholder expectations. /liliLead the ongoing medical/scientific review of clinical trial data across assigned studies in collaboration with the medical expert and key line functions, and partners on data analysis and data interpretation, including safety trend analysis, signal detection, development of first interpretable results, reporting clinical study results in CSR, and internal/external publications. /liliPrepare and lead dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, to provide consolidated information for dose escalation meetings and Phase II data reviews with relevant stakeholders. /liliProactively lead risk mitigation discussions, risk management and implementation at the trial level. /liliResponsible and accountable for forecasting and managing overall study budget(s) in collaboration with key partners. /liliCollaborate with key partners to set vendor strategy and timelines for assigned studies. /liliResponsible for implementation of best practices and standards for trial management, including sharing lessons learned. /li /ulh3QUALIFICATION KEY COMPETENCIES: /h3ullibRelevant working/residency permit or Swiss/EU-Citizenship required. /b /liliBachelors in life science/healthcare required; Advanced degree or equivalent education/degree in life sciences/ healthcare preferred (PhD/MD/ PharmD/ Masters). /lilibApproximately 6+ years’ experience in clinical trials development. /b /liliFor TCO: bStrong understanding of oncology/haematology /b and demonstrates high learning agility. /liliFor TM: Demonstrates high learning agility in therapeutic area. /liliProficient in bclinical trial methodology with a strong emphasis in early clinical development. /bStrong operational project management experience including excellent planning, prioritization, problem solving and organizational skills. /liliDemonstrated ability to confidently drive complex collaborations, demonstrates leadership, interpersonal skills, willingness to adapt, and willingness to speak-up and challenge. /lilibTrack record of successfully managing or leading multiple complex clinical trials concurrently. /b Used to managing multiple priorities. /liliDemonstrated capability to interpret, discuss and represent trial level data. /lilibWorking knowledge of clinical finance principles /bto manage efficient expenditure to minimize variance between actual and forecasted spend. /lilibMaintain extensive knowledge of ICH-GCP /b, external regulations and procedures, and supplements by training and practice of the company`s SOPs and internal policies. /lilibLanguages: Fluent oral and written English. /b /li /ul /p #J-18808-Ljbffr
