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Job Details

Medical Director/Sr. Medical Director - Remote

Company: SynteractHCR Deutschland GmbH
Location: Carlsbad, CA
Reference: 27250-DR
Closing Date: 13 Jan 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Overview   Must have Medical Monitoring experience to be considered, with CRO experience highly preferred.   The Medical Director/Sr. Medical Director is responsible for providing medical advisory support for Sponsors in 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...

Requirements:

Overview

 

Must have Medical Monitoring experience to be considered, with CRO experience highly preferred.

 

The Medical Director/Sr. Medical Director is responsible for providing medical advisory support for Sponsors in 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. This position can be based in Morrisville, NC, Carlsbad, CA, or home based Anywhere, US .

 

Responsibilities

  • 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 advisory input to business development activities including proposal development, feasibility input, and sales presentations.

Qualifications

Academic & Professional Qualifications:

  • Medical Doctor or DO reqjuired.  Oncologist highly preferred.  Other specialties will be considered.
  • Minimum 2 years experience working as an MD.
  • Active medical license is optimal, not mandatory.

Skills & Experience:

  • In-depth knowledge of medical terminology and of GCP, ICH guidelines relevant to global drug safety, and the drug development process and regulations.
  • Minimum 2 years experience working in ICH-GCP clinical trials
  • Proficiency in Microsoft Office; Word, Excel, PowerPoint, Outlook as required.
  • Effective verbal and written communication skills in both English and local languages, if applicable.

What We Have to Offer

Our team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations

 

Who We Are

Synteract is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With our “Shared Work – Shared Vision” philosophy we provide customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 15 countries, we deliver trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.

 

Our mission is to support the innovation and development of better therapies in healthcare. Our focus on patients’ safety and comfort helps us to establish ethical standards for everything we do.

 

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: Medical Director/Sr. Medical Director - Remote

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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