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Study Manager

Posted on Oct 9, 2020 by ITech Consult

Risch, Zug, Switzerland
Research
Immediate Start
Annual Salary
Contract/Project

Study Manager - Medical Device Study Management, biochemical, chemical and biophysical area, IVDD/IVDR, FDA

Role:
For our client in the Pharma industry based in Rotkreuz we are looking for a Study Manager.

Areas of responsibility:
- Overall accountability for generation of evidence ensuring that the sponsor responsibilities are fulfilled, while assuring compliance to all applicable regulatory requirements (eg FDA, IVDR).
- Prepares different scenarios for generation of evidence (eg study, RWE)
- Proposes evidence generation strategy to the MSA Project Team (in cooperation with the MSA Func.Rep) - Leads the global study team with full accountability for the study with respect to scientific content, quality, cost and timelines. Aligns on roles and responsibilities of team members
- Ensures and is responsible that high quality study designs are translated into evaluation plans for design validations/performance evaluations and clinical studies pre-DCC, during DCC and post-launch and that these are developed in cooperation with internal and external experts
- Ensures close collaboration with MSA Functional Representatives in the MSA Project Team to support planning of timeline and cost (as needed in cooperation with the MSA Func.Rep)
- Ensures close cooperation with Regulatory Affairs, Biometrics, DIS and other external functions to support global submission strategies
- Develops study design for technical studies in coordination with internal and external experts and the development/project team with full responsibility for study protocol and study report
- Provides input to study synopsis prepared by Clinical Science for Clinical Utility and Clinical Performance studies and ensures that these studies are executed based on study synopsis with
full responsibility for study protocol and study report
- Owns the study budget in cooperation with the Study Team
- Accountable for site selection in collaboration with Investigational Site Management
- Oversight on COSS support (eg contracting, sample acquisition and management, logistics etc.)
- Planning and oversight of tasks and work packages for external collaborators in collaboration with the appropriate function
- Provides CRO oversight in fully or partially outsourced studies in alignment with the Global Strategic Sourcing Lead
- Accountable for data and study result validation, interpretation, drawing of recommendations and communication to Principal Investigators, the MSA Project Team and other teams as needed
- Ensures that generated evidence is provided and documented in a timely fashion and ensures that study results are published in collaboration with the Publication Team
- Ensure compliance to all relevant to client safety and QM procedures
- Accountable for archiving and audit/inspection readiness
- Responsible to bring external know-how in-house for the development of new products and innovative study designs through the scientific interaction with international KOLs, Principal Investigators and end-users
- Continuous follow up on market developments and competitor products
- Ensures in-depth scientific expertise for cross-functional teams within and outside of MSA in the relevant indication area
- Gives input into ClinOps Q documents (process ownership)
- Provides mentoring for new hires while onboarding and Study Managers (at all levels) to ensure that their role and contribution is optimized

Professional and technical requirements:
- PhD/PharmD/MD in Life Science and/or relevant disease area expertise
- More than 3 years of experience in IVD (preferred) or Medical Device Study Management in all stages of international clinical trials, study protocol design, report writing and leading Matrix teams
- Experienced in biochemical, chemical or biophysical area with detailed knowledge in specific fields of diagnostics (eg coagulation, cardiology)
- Knowledge of applicable standards and regulations for clinical trials and lab conduct (International Conference on Harmonization/WHO Good Clinical Practice standards (ICH-GCP),IVDD/IVDR, FDA regulations)
- Has special scientific knowledge in a therapeutic or diagnostics/systems area
- Statistical knowledge
- Fluent in English
- Demonstrated experience in computer skills
- Prepared to travel (National & International)

Nice to Haves:
- "Can do"-mentality
- Learning agility, creativity and ability for development of new concepts
- Open, active and clear communicator (written and verbal)
- Professional communication style and business behaviour in interactions within and outside of Pharma, eg with customers and KOLs
- Ability to manage virtual teams in global studies
- Confident and influential approach, ability to provide clear instructions/directions to teams at the same level and at higher levels in a global organisation

Reference no: 919742 AD
Role: Study Manager
Industry: Pharmaceutical industry
Workload: 100%
Location: Rotkreuz, Switzerland
Start date: 02.11.2020
Latest start date: 16.11.2020
Duration: 12 months contract, with possible extension

About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.

Reference: 968038110

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