Please refer to JobSuchmaschine in your application
Global Clinical Trial Project Manager, Autoimmune or Musculoskeletal
Job ID192525BRPosition TitleGlobal Clinical Trial Project Manager, Autoimmune or MusculoskeletalDivisionNIBRBusiness UnitTranslational MedicineCountrySwitzerlandWork LocationBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentTherapeutic/Disease AreaAutoimmunity, Transplantation & InflammationJob TypeFull TimeEmployment TypeRegularJob DescriptionAs a Senior Clinical Scientist / Global Clinical Trial Project Manager, you will be accountable for all aspects of the management and clinical execution of early phase Autoimmune or Musculoskeletal clinical trials within Translational Medicine (TM). You lead the planning and implementation of all operational aspects of TM 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 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.
About Clinical Sciences & Innovation:
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 and includes Biomarker Development, Discovery & Profiling (Physician-Scientists), Drug Metabolism & Pharmacokinetics, and Pre-Clinical Safety.
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, co-ordinating study execution and monitoring enrolment and data flow/scientific review.
1. Clinical Scientist for Phase I/II including multi-country / multi-center trials. Your 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, Therapeutic Area 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 requirementsMinimum requirements- PhD level scientist with life sciences background; PharmD; BSc or MSc in life sciences
- Business-level written and oral English
- At least 6+ years experience in sponsor clinical trial management and execution, plus drug development
- Extensive knowledge of Good Clinical Practice
- Track record of successfully managing multiple concurrent global phase I and IIa, multi-country/site complex clinical trials
- 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 active/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 in a changing environment
- (auto) immunological or diseases/conditions related to muscle, connective tissues, joints or bone