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Senior Clinical Data Manager at Katalyst HealthCares & Life Sciences

unlimited holidays - extra holidays - extra parental leave - long remote period allowed

Remote:

Full Remote

Experience:

Mid-level (2-5 years)

Work from:

United States

Offer summary

Qualifications:

BA/BS in science related field, 4-5 years of experience in clinical data management.

Key responsabilities:

Coordinate Database build and review CRF design
Provide guidance for outsourced Data Management activities
Conduct User Acceptance Testing activities as needed
Perform external data reconciliation and SAE reconciliation
Review clinical trial data, resolve queries, and track data cleanliness status

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities: :

Coordinate Database build, Design CRF, author/review Data Management Plan, Data Validation Plan, Edit check specifications and CRF Completion Guidelines per agreed study timelines.
Review and provide guidance/inputs to CRO for all outsourced Data Management activities including but not limited to CRF design, Data Management Plan, Data Validation Plan, Edit check specifications and CRF Completion Guidelines.
Participate in User Acceptance Testing activities as needed.
Liaise with Safety team or Lab vendors and perform/oversee External data reconciliation and SAE reconciliation.
Conduct review/QC of clinical trial data; write/resolve queries and track the status of data cleanliness and perform all tasks required for database lock.
Respond and provide trial related support to cross functional groups such as Biostatistics, Clinical Research, etc.
Attend meetings and report on study status, metrics, timelines, etc.
Other data management department and trial related activities as delegated
Prior experience of working with studies across all phases or Clinical Development (Phase I – III). Specialized experience with Phase I studies or Post Marketing Surveillance studies or experience of working with Real World Data is a plus.
Familiarity with tools such as J review, SAS and Excel and proficiency with Electronic Data Capture systems preferably with Medidata Rave. Knowledge of e-source/ePRO/eCOA data is a plus.
Familiarity with CDASH, SDTM and medical terminology principles in relation to study design
Good working knowledge of GCP