Country Monitoring Manager

Location: 

Philadelphia Area, Cherry Hill, NJ, US

 

 

About Idorsia Pharmaceuticals Ltd

 

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

 

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.

 

Headquartered in Switzerland, Idorsia is specialized in the discovery and development of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

 

Idorsia has US operations based in Cherry Hill, New Jersey with 20 professionals supporting the clinical development of our innovative pipeline in North America.

 

Job Responsibilities

 

  • Management of the daily functions of the inhouse start up and clinical operations group
  • Provide input to the trial documentation prior finalization (e.g., protocol, Informed Consent, diaries, CRFs)
  • Support the (Sr) Clinical Operations Coordinator in the submission planning of ECs/IRBs submissions
  • Support the operations team in the development of specific tools for the sites and Clinical Research Associates, in accordance with standard templates
  • Assist in conducting Site Quality Visits with clinical trial sites
  • Ensures quality of monitoring deliverables for the Operation Coordinators
  • Support the review and approval of all types of visit reports (e.g., Site Selection Visit, Site Initiation Visit, routine Monitoring Visits, Close-out Visit, including issue management until resolution in a timely fashion

 

Candidate Requirements

 

  • Extensive knowledge in clinical development with strong emphasis on monitoring and site management processes
  • Minimum Bachelor’s degree or healthcare profession degree
  • 8 years' experience in monitoring and conducting clinical research; Monitoring of clinical trials in different countries is an advantage
  • Previous involvement in study start up processes, investigator contract management and experience in preparing documents for submission to Ethics Committees/Institutional Review Boards
  • Experience in working with electronic data capture, electronic Trial Master File and Clinical Trial Management Systems
  • Strong computer skills including proficiency in Microsoft (MS)-based applications (e.g., Word, Excel, and PowerPoint)
  • Excellent verbal and written communication skills in English; and other language(s) as appropriate for country
  • Position requires international travel
  • Excellent relationship-building, problem solving and planning skills
  • Good communicator, with good organization and negotiation skills having worked in a cross-functional team environment
  • Proven record of driving decisions through effective influencing skills, presenting clear messages from complex information/data to all levels in the organization

 

 

Physical Requirements

  • Talk, hear, and use fingers and hands to perform repetitive motions (computer work).
  • Carry up to 20 pounds of weight occasionally.
  • Close visual acuity to perform activities such as preparing and analyzing data and figures.

 

 

What Idorsia offers

 

  • Potential to telecommute 1-2 days a week (after 90 day probation period) with supervisor approval.
  • Exciting opportunities for development and professional growth within our dynamic organization.
  • A collaborative and solution oriented enviroment where you can make a difference.
  • An innovative and open culture in a truly multicultural environment.
  • A competitive salary and generous benefits.

 

Work  Location: Philadelphia Area - Cherry Hill

Country: USA

Business Area: Global Clinical Development

Schedule: Fulltime

Job Type: Permanent

Job ID: 1161

 

If you are interested, please click on apply now.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.

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