Celgene (Senior) Clinical Research Associate in Munich, Germany

Description

Location: Munich office

Under the supervision of the Associate Manager Clinical Research and within the framework of the global Clinical Research function, the individual monitors investigative sites.

Responsibilities include but are not limited to:

  1. Monitor assigned investigative sites
  • Plan and conduct pre-study, initiation, interim monitoring and close-out visits

  • Serve as main point of contact with assigned investigative sites

  • Train assigned investigative sites in Good Clinical Practice and associated regulations

  • Monitor compliance with protocol, informed consent process, drug accountability, GCP and applicable laws

  • Conduct Source Data Verification

  • Monitor status of supplies (e.g. study medication, lab kits) at site

  1. Perform remote monitoring and analysis
  • Evaluate study query trends and interact with Study Team in improving data quality

  • Work with Data Management and investigative sites to facilitate query resolution

  1. Attend, participate and present at Investigator meetings

  2. Perform Ethics Committee and local regulatory submissions

  3. Perform CRO oversight including co-visits for assigned indications

  4. Identify new investigators for future Celgene studies

  5. Assist in mentoring new CRAs, as requested

  6. Participate in global company initiatives

  7. Up to approximately 60% domestic travel required, including overnight stays

Qualifications

  • Strong identification with Celgene’s values

  • Broad experience as a Clinical Research Associate

  • Must have demonstrated problem-solving abilities in overseeing clinical sites, and demonstrated tactfulness and diplomacy in dealing with study coordinators and physicians

  • Experience in study / site set up

  • Able to resolve issues independently

  • Good knowledge of regulatory environment (ICH-GCP, relevant European and German laws)

  • Excellent written and oral communication skills

  • Good knowledge of MS Office and eCRF programs

  • Fluent written and spoken English

  • Prior hematology clinical study experience preferred

  • Valid driver’s license

*LI-POST

(Senior) Clinical Research Associate

Location: Munich, BY, DE

Job ID: 17001356