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    • April-07-14
    • Full Time
    • Experienced
    • Recruitment and Staffing

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Clinical Study Manager

RENAUDEXEC

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At RENAUDEXEC, we're committed to knowing who you are, what you're searching for and supporting your future aspirations. We work to achieve the best match between you and one of the many life sciences organizations we serve.

We pride ourselves on:

DISCRETION

Our relationship with you is strictly confidential. Your information shall be conveyed only with your permission.

ATTENTIVE LISTENING

We have to ask you questions, but first and foremost, we have to listen attentively to get to know who you are and what you seek.

RESPECT

Respect is of paramount importance to us; we intend to treat you with respect as well as to earn your respect.

FOLLOW-UP

We know that job seeking can be a time where anxiety may increase. This is why we commit ourselves to do frequent and serious
follow-ups.

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Director - Clinical trials
 
Job : 091329 - Director - Clinical trials
Field : Medical , Pharmaceutical
Region : Washington, DC
Job description :

 

The Clinical Study Manager assumes overall responsibility for the day to day management of clinical trials, ensuring compliance with all regulatory and GCP requirements as well as within budgets and timelines.

 

  • Participate into clinical trial protocols / Case Report Forms (CRFs) development;
  • ? Interact with internal and external customers involved in projects;
  • ? Ensure that clinical trials are conducted in full compliance with Good Clinical Practices (GCPs), internal Standard Operating Procedures (SOPs) and all other requirements (e.g., regulatory) as well as in accordance with study milestones and budgets;
  • ? Collaborate with CTA (Clinical Trial Administrator) and other Clinical Team members to ensure contractual and regulatory documents are properly managed;
  • ? Responsible, with the Medical Affairs Director, for the Medical Devices Vigilance;
  • ? Manage the Clinical Study Supplies (shipment, inventory, destruction, etc.);
  • ? Manage budget, timelines in relation to trials advancement;
  • ? Participate into clinical sites evaluation and selection;
  • ? Oversee patients recruitment;
  • ? Facilitate and participate in audits (internal and/or external);
  • ? Participate in clinical meetings with Investigators;
  • ? Work closely with Clinical Research Associate (CRA) responsible for study monitoring;
  • Work closely with CRO
  • ? Collaborate in study results collection, analysis and reporting;
  • ? Other duties as assigned.

Specific skills and qualifications :

  • Bachelor's s degree in Health Sciences;
  • A minimum of 7 years of clinical experience acquired in pharmaceutical/biotechnology/medical devices companies and/or CMO/CRO settings.
  • Knowledge of USA clinical research regulations required
  • Knowledge of clinical research methodology, ethical, regulatory, GCP and ICH guidance;
  • Budgets management and contract negotiation experience;
  • Results-oriented professional with the ability to think strategically and creatively;
  • Very strong ability to manage multiple tasks with competing priorities in a demanding, fast-paced and entrepreneurial R&D environment;
  • Dedicated self-starter with strong organizational skills and committed to the achievement of objectives;
  • Highly developed interpersonal skills with the ability to work equally well independently and in a team environment;
  • Good communication skills, confident and articulate; 
  • Proficient in computer applications and softwares;
  • Ability and willingness to travel (approx. 25-30%), as required.
   
If you are interested in this job, please contact Chantal Melançon by email at chantal@renaudexec.com and state the job title and offer number : 091329
 

We thank you for your interest, however, only those selected for an interview will be contacted.

 

Our commitment:

Confidentiality, follow-up, listening and respect


 
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