International Clinical Trials Scientist/Project Manager, early phase
Inseriert am: 11.05.2018
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Apply to JobJob ID238971BRPosition TitleInternational Clinical Trials Scientist/Project Manager, early phaseSourcing Statement You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV.Job DescriptionAs an international Clinical Trial Scientist/Project Manager you will be accountable for all aspects of the management and clinical execution of early phase clinical trials across different therapeutic areas within Translational Medicine (TM). You lead the planning and implementation of all operational aspects of clinical trials from study concept to reporting according to timelines, budget, operational and quality standards. You are responsible for program-level activities and may have project lead roles that include strategic partnering and within Clinical Sciences & Innovation (CS&I) as well as Global Pharma throughout the development of a compound or complex patient populations, oversight and understanding of all CS&I trials within that project, oversee junior team members and lead a global study team, participate on project level decision making, manage scientifically and operationally complex studies.
Major accountabilities:
1. Clinical Scientist for Phase I/II including multi-country / multi-center trials. The main focus will be on high complexity studies leading to clinical Proof-of-Concept or NDA registration
2. Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) and support functions to ensure all trial deliverables are met. Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to CTT, CS&I Management, TA Heads and Project team members
3. Lead all aspects of study planning and in collaboration with outsourcing/feasibility personnel, CTT members, local country office representatives and CRAs. Identify sites and manage study set-up, including responsibility for organizing and chairing investigator meetings, or site initiation meetings
4. Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised
5. Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility
6. May support the Medical Expert on project documentation e.g. briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc.
7. Lead the ongoing medical /scientific review of the clinical trial data (in collaboration with the Medical Expert and CTT), coordinate the data analysis and interpretation of first interpretable results, publications and internal/external presentations. Direct the data review and interactions with the Data Manager, Statistician, and third parties to ensure high quality data are transferred/available in a timely manner
8. Accountable for Clinical Study Report writing and publication of studies, either directly contributing to and managing the report writing, or by liaising with the medical writing/narrative group to ensure report is completed according to current requirements
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About Clinical Sciences & Innovation:
CS&I is part of Translational Medicine, a single global team of Physicians and Scientists that bridge drug discovery and clinical application. The CS&I group is a global team of Clinical Scientists and support functions that plan and manage Novartis Institutes for BioMedical Research Phase I and Phase IIa clinical trials worldwide. Our trials profile safety, tolerability, pharmacokinetics, pharmacodynamics, and early proof of efficacy of novel compounds in healthy volunteers and patients: key tasks include leading authorship of study protocols and input to study designs, identifying study sites and investigators, negotiating external study contracts, coordinating study execution and monitoring enrollment and data flow/scientific review.Minimum requirements- PhD level scientist preferred with life sciences background otherwise PharmD, MSc or BSc in life sciences
- Business-level written and oral English
- At least 6+ years experience in international Pharma / Sponsor clinical trial management and execution, plus broad knowledge of drug development
- Extensive knowledge of Good Clinical Practice.
- Track record of successfully managing multiple concurrent phase I and IIa, multi-country, multi-site clinical trials
- Ideal therapeutic area experience: autoimmunity, dermatology, musculoskeletal, respiratory - other areas fine for a strong clinical trial leader/project manager
- Office and clinical trial software IT computer literacy
- Demonstrated leadership and problem-solving skills
- Strong operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities
- Clear written and verbal expression of ideas, an proactive communicator
- Well-developed interpersonal skills with a proven track record of successfully interacting with and influencing with a wide range of people, building strong positive relationships
- High level of customer orientation awareness and focus
- Used to working independently and in a team environment, being flexible and adapting to changeDivisionNIBRBusiness UnitTranslational MedicineLocationSwitzerlandSiteCompany/Legal EntitySwitzerland Novartis AG, BaselFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegular
