Regional Director of Clinical Affairs and CRO Europe based in Germany

Job Description

Our client is a leading, global medical device company pioneering noninvasive surgical treatments.

The Regional Director of Clinical Affairs will work closely with senior management to translate business commercial objectives into requirements for specific clinical trials and programs.

This role is responsible for the successful execution of the EU clinical portfolio as well as the management, growth and development of the clinical staff.

Skills and Experience :

1) BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplines

2) Minimum 5+ years in clinical management position in the Medical Device industry (Class 2B / 3) / or Clinical Research Organization.

Bio-pharmaceutical experience would provide a strong advantage

3) Additional 5+ years direct experience in clinical trial management

4) Solid track record in successfully executing Phase I III clinical trials

5) Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH, ISO guidelines. FDA and / or Health Canada experience would provide a strong advantage

6) Strong, hands-on manager with experience in managing clinical affairs staff, Core Labs, data management, bio-statistics, and medical safety reporting

7) Knowledge of electronic data capture systems and web-based clinical trial management tools

8) Strong program management and financial skills

9) Fluent English skills. Additional European languages will be an advantage.

10) Willing & able to travel domestically and internationally, as required (up to 40%)

Responsibilities :

Strategic translation of business objectives into successful clinical requirements for clinical trials, investigator-sponsored studies, publications, etc, and by meeting EU regulatory requirements for clinical evaluations and post-market surveillance

Manage and develop global internal team of Clinical Project Managers and outside vendors, as needed

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 trial

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

Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications

Develop, maintain and expand collaborations with Company Stakeholders, outside clinical investigators, researchers and key opinion leaders to facilitate the optimum performance of clinical development programs

Develop 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

Provide oversight of investigator-sponsored studies

Develops budget for all clinical projects and adhere to company financial goals