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Lead Clinical Data Manager

unlimited holidays - extra holidays - extra parental leave - long remote period allowed
Remote: 
Full Remote
Experience: 
Senior (5-10 years)
Work from: 

Offer summary

Qualifications:

Minimum 10 years CDM experience in life science industry with Bachelor's degree, 5+ years Medidata RAVE experience.

Key responsabilities:

  • Lead and manage up to 2 Phase II studies as Study Lead CDM
  • Manage DM activities, design CRFs, and ensure data accuracy
  • Initiate, manage study activities, review DM study plans
  • Ensure timely database lock with vendors, conduct UAT
  • Collaborate with cross-functional teams for reliable data
Katalyst HealthCares & Life Sciences logo
Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/
51 - 200 Employees
See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:
  • Act as the Study Lead CDM for up to two, Phase II studies
  • Manage DM activities for all assigned studies, develop/design CRFs, and full UAT
  • Responsible for initiation and management of study activities and documentation
  • Responsible for review of DM study plans including DMP, Data Validation Plans, etc.
  • Work closely with cross-functional clinical teams to ensure data accuracy, reliability and consistency
  • Ensure study databases are locked per the criteria and timelines by working together with the vendors and study teams
  • Other Data Management related duties as needed
  • Demonstrated expertise managing and executing full study start-up through close out DM activities and all data management related documentation (SOPs etc)
  • Experience conducting User Acceptance Training in Medidata Rave, performing edit check specifications, etc. is a must
  • Experience in CRO and vendor management
  • Experience with multiple phases of clinical development
  • development of treatments for rare and serious diseases
  • working as a Data Management Study Lead, responsible for managing two concurrent Phase II clinical studies within one of the client's drug programs.

Requirement:

  • Minimum of 10+ years of clinical data management experience in the life science industry and bachelor's degree (Sponsor experience is preferable)
  • 5+ years of experience with Medidata RAVE (recent)
  • At least 4-5+ years of strong experience as a Lead Clinical Data Manager responsible for multiple clinical studies at one time
  • Excellent communication skills and ability to work in a cross-functional team environment
  • A strong degree of willingness and ability to wear multiple hats, work very hands-on and collaborate closely with the team is required.

Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Verbal Communication Skills
  • Organizational Skills

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