Clinical Affairs Program Manager - Neurosurgery Medical Devices

  • Job Reference: 00000021-1
  • Date Posted: 17 January 2021
  • Recruiter: Coberon Chronos Group
  • Location: EU
  • Salary: On Application
  • Sector: Medical Devices / MedTech, Telecom, Service & Support Engineers, Professional Services & Consulting, Clinical & R&D, NFV Network Functions Virtualization
  • Job Type: Permanent, Full-time, Home-office based, W2

Job Description

Our client is a fast-growing, global medical device company focusing on non-invasive treatments for some of the most challenging diseases. This is a full time, permanent position with flexible location.

The Clinical Affairs Program Manager – Europe is part of the Global Clinical Affairs Management team and is responsible for execution of Global Clinical Affairs studies in Europe. In particular, the Clinical Affairs Program Manager – Europe is responsible to develop strategies for a successful execution of roadmap clinical trials that demonstrate medical product safety and efficacy. Additional responsibilities include management of clinical trials approvals with local IRBs and/or Competent Authorities.

Skills and Experience:
BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplines
Minimum 3+ years in clinical management position in biopharmaceutical or device industry, Clinical Research Organization Biopharmaceutical experience would provide a strong advantage
Additional 4+ years direct experience in clinical trial management
Solid track record in successfully executing Phase I – III clinical trials
Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH, ISO guidelines. FDA and or Health Canada experience would provide a strong advantage
Strong, hands-on manager with experience in managing Core Labs, data management, biostatistics, and medical safety reporting
Knowledge of electronic data capture systems and web-based clinical trial management tools
Excellent interpersonal, written / verbal communication & organizational skills
Excellent command of the English language; both written and verbal. Additional language beside native language is a significant advantage
Collaborative team player with strong abilities to operate independently
Strong program management and financial skills
High level computer skills required (e.g. MS Word, Excel, PowerPoint)
Willing & able to travel domestically and internationally, as required (up to 40%)
* Only qualified applicants will be considered

Responsibilities:
Collaborate with Company Stakeholders to execute company objectives into successful clinical trials, investigator-sponsored studies, etc.
Overall responsibility for design of clinical trials including protocol development, clinical trial discussions with EU Competent Authorities, and development of timeline and budget
Manage the process of screening/qualifying, selecting, and contracting with investigators, sites and vendors required for conduct of clinical trials
Direct/Manage necessary clinical trial approvals from IRBs/ECs, and ensure studies are on track for site initiation, patient recruitment and enrollment; take corrective actions where necessary to address issues
Develops budget for all clinical projects and adhere to company financial goals
Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications
Develop, maintain and expand collaborations with Company Stakeholders, clinical investigators and researchers, and key opinion leaders to optimize the clinical development programs
Participate in the development of SOPs and work instructions to assure internal files and clinical study files (patient; site; country) conform to Good Clinical Practice regulations and standards
Ensure adherence to protocols and compliance with regulatory (FDA/ICH/ISO/GCP) guidelines as well as SOP procedures
Identify clinical training needs and develop training materials for in-house and clinical site use