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PHYSEON, established in 2015 and located in Schaffhausen, Switzerland, is a boutique medical device company created to guide the development and commercialization of new innovations in healthcare. We embrace research and science to bring about innovative ideas and medical products that can advance the health and well-being of patients and simplify processes for healthcare professionals. Committed to applying the latest technology and engineering, we seek to rethink current limitations and achieve the unthinkable with simple, superior products.

 

Make your next career move count!

Can you see yourself driving business success to new levels? Would you like to play a major role in deciding and shaping your own career? Do you value flat hierarchies and a performance driven environment? If so, we have an opening for a

 

CLINICAL RESEARCH MANAGER
 

The Clinical Research Management is responsible for leading or participating in one or more cross functional study teams (and/or sub-teams) to deliver clinical research studies on time, within budget and with good quality in compliance with Regulatory Authorities’ regulations/guidelines and Physeon`s  SOPs. This role applies to internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with therapeutic area medical director(s) and assigned therapeutic area product manager.

Studies are currently ongoing or planned for this year in patients with cancer, renal insufficiency and patients with difficult venous access.

 

Responsibilities:
 

Study Leadership

  • Build, manage, and maintain budgets, contracts and timelines for the clinical trial

  • Prepare content for training materials and coordinate training on study procedures

  • Establish study team contacts, roles, responsibilities, and objectives

  • Develop, manage, and maintain relationships with external partners

  • Develop study execution plans and risk management plans

  • Facilitate communication between study sites to ensure successful execution

  • Establish and execute risk management plans when required

 

Study Planning

  • Serve as project manager for the functional area in managing protocol execution

  • Oversee study planning and timelines to ensure alignment with overall clinical development plan

  • With input from therapeutic area medical advisers and consultants,  lead the development of study documents including protocols, informed consent forms, and study manuals

  • In collaboration with Regulatory and Quality Affairs Manager, responsible for meeting timelines of investigational product manufacturing, labelling, release and management

 

Selection and Evaluation of Investigative Sites

  • Identify prospective investigative sites, liaise with vendors to ensure quality and participate in final site selection

  • Monitor GCP/ICH site level compliance

 

Identification and Management of Vendors

  • Oversee all aspects of vendor management (performance, quality, timelines, deliverables, costs)

  • Ensure appropriate escalation of issues as they arise

 

Preparation of Study Documentation

  • Review essential regulatory documents

  • Prepare, review and approve Monitoring Plan, eCRF specs (EDC) and review CRF completion guidelines

  • Design, review and approve study tools (for investigative site use)

  • Facilitate development, review, and approve Data Management documents (CRO and in-house studies)

 

Input Clinical Database, Safety and CSR Reports

  • Oversee the development of procedures and tools for data collection

  • Oversee collection of data to ensure compliance with protocol and clinical research project objectives, FDA / ICH / GCP regulations and guidelines

  • Participate in SAE reconciliation

  • Review and compile CSR and appendices

 

Initiation and Site Start Up

  • Plan, organize and lead investigator meeting and prepare and review materials

  • Provide oversight of country regulatory approvals (e.g. CTA, MoH) in consultation with Regulatory and Quality Manager

  • Oversee country / site IRB / EC approval

  • Review regulatory package (essential documents - blank forms and templates for FDA 1572s, financial disclosure, etc.)

  • Obtain appropriate country / site insurance

  • Authorize investigational product shipment to investigational sites, including the initial shipment

 

Enrolment of Subjects (in collaboration with Data Management vendor when applicable)

  • Ensure enrolment is tracked and recorded appropriately

  • Address enrolment and retention issues

 

Maintenance of Sites, Subjects and Data (in collaboration with Data Management vendor when applicable)

  • Provide oversight of clinical monitoring to ensure quality data (in-sourced or out-sourced)

  • Follow up on outstanding eCRFs and data queries

  • Address site issues found during audits

  • Compile materials and data to support Data Safety Monitoring Board

Study Close Out

  • Manage / oversee study close out activities

  • Complete all archiving

  • Reconcile TMF

 

Requirements:
 

  • Bachelor’s degree in Sciences,  Pharmaceutical  sciences or nursing  and 8-10 years’ experience in the pharma / life science industry

  • Experience developing trial plans, extensive clinical research knowledge and a cross-functional understanding of clinical trial methodology

  • Working knowledge of the clinical medical device development process

  • Proactive and comfortable with start-up culture

  • Understands current and future business trends and information

  • Effective problem solving skills

  • Excellent interpersonal skills.  English: fluent / German: desired. Written, verbal communication and presentation skills in small and large group settings

  • Knowledge of ICH /GCP and regulatory guidelines / directives

  • Disease / therapeutic area knowledge

  • Leadership skills / negotiation skills, mentoring / coaching, ability to effectively multi-task and prioritize

  • Financial budgeting and forecasting skills

  • Project management / organizational skills. Solid computer skills in MS applications including (but not limited to) MS Project, Word, Excel

  • Study Tools including electronic system skills CTMS / EDC

  • Cross functional and cross-cultural awareness

 

Core competencies:

 

  • Dealing with Ambiguity

  • Business Acumen

  • Drive for Result

  • Planning

  • Time Management

 

This full time role requires US / UK / European business travel of approx. 60-70%

 

Candidates must be eligible to work in Switzerland

If you have the relevant skills and experience and are looking to grow in an international, dynamic and entrepreneurial environment please submit your application here.

Clinical Research Manager