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Job Details

Sr Medical Director - Neurology

Company: SynteractHCR Deutschland GmbH
Location: United States Anywhere, US None
Reference: 27574
Closing Date: 15 Dec 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Senior Medical Director - Neurology - Anywhere, US Office-based or Remote-based   Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in...

Requirements:

Senior Medical Director - Neurology - Anywhere, US

Office-based or Remote-based  

Who We Are

Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neurodegenerative Diseases, and Rare and Orphan Diseases, including expertise in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.  

Position Overview

The Sr. Medical Director - Neurology is responsible for providing medical advisory support and leadership for the Neurodegenerative Center of Development by overseeing medical issues in phase I – IV clinical trials with a primary focus on protecting the safety of study participants and ensuring that all medical issues are recorded and reported in accordance with the clinical trial protocol, standard operating procedures (SOPs), good clinical practice (GCP), and all other applicable regulatory requirements.  

Specific tasks would include:

 
  • Provide project physician support to clinical study teams during the execution of clinical research studies, including protocol development, eCRF development, therapeutic area training, protocol queries, patient eligibility determination, clinical/safety data review, and clinical summary report generation.
  • Liaison with external clients, IRBs, DMCs, vendors, and regulatory agencies for study-related medical issues.
  • Provide medical advisory input to business development activities including proposal development, feasibility input, and sales presentations.
  • Educates the study team on medical aspects of conducted or planned clinical trials.
  • Participates in study start-up, investigator, client meetings, Federal Drug Administration (FDA) meetings, meetings with National authorities.
  • Reviews and contributes to medical aspects of trial-related documents such as Medical Monitoring Plan, Study Protocol, and Investigator Brochure.
  • Reviews medical aspects of protocol eligibility/compliance, waivers, deviations, dose escalation determinations, CRFs, clinical study reports, and regulatory submissions.
  • Reviews laboratory results and results of other examinations of study subjects.
  • Collects, monitors and analyzes information related to adverse events (AEs) and serious adverse events (SAEs). Reviews associated safety case narratives to assure claims of causality and expectedness are reasonable and medically sound.
  • Reviews or assists in the review of medial coding to assure congruency with the terms reported in the case report form (CRF) and provides re-coding of event if appropriate.
  • Participates in masked or unmasked data review and Data Safety Monitoring Board activities.

Qualifications

  • Medical Doctor or DO, board certification in neurology preferred
  • Minimum 5 years’ experience working as a medical advisor/medical monitor in CNS/neurology clinical trials.
  • Active medical license is optimal, not mandatory.
  • In-depth knowledge of medical terminology and of GCP, ICH guidelines relevant to global drug safety, and the drug development process and regulations.
  • Proficiency in Microsoft Office; Word, Excel, PowerPoint, Outlook as required.
  • Effective verbal and written communication skills in both English and local languages, if applicable.   If you’re passionate about bringing clinical trials to life, we encourage you to apply today!    Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.

Apply for this job: Sr Medical Director - Neurology

Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

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