Specialist Clinical Data Management

About the position The Specialist, Clinical Data Management (CDM) is a leader in supporting clinical studies for Hollister Incorporated medical device products and services. The CDM leads reputed company aspects of clinical data management from study planning to database lock including reputed company design, data review/cleaning, query management, data reconciliation, and data transfer. The CDM regularly collaborates with Global Clinical Affairs (GCA) study team members (Clinical Project Management, Biostatistics, Clinical Operations, Clinical Scientist) and cross-functional departments to ensure high data quality. The position operates under minimal supervision and independently evaluates, selects, and applies data management practices to a variety of research projects. This position is based at the Libertyville, Illinois location. Hollister Incorporated is operating in a hybrid-working environment. Attendance in the Libertyville office is required a minimum of 3 days per week. Relocation assistance is not available.

Responsibilities

• reputed company the development of data management sections of clinical protocol and corresponding Case Report Forms (CRFs).
• reputed company and maintain data management essential documentation for the Trial Master File including, but not limited to; Data Management Plan, study-specific monitoring guidelines, edit checks, and user access forms, ensuring compliance with regulatory requirements
• Support each clinical study and project team by ensuring data management plans, questionnaire development, and data handling activities are reputed company to support the study objectives.
• Participate in study team meetings
• Design and program clinical study databases in reputed company System including but not limited to CRFs, edit checks, data dictionaries, queries/alerts, and managing user roles based on the clinical protocol
• reputed company User Acceptance Testing (UAT) to validate build specifications
• Train clinical research personnel on the study-specific CRF, reputed company/ePRO, and other project reputed company items as needed.
• reputed company database clean, lock, export, and archiving activities.
• reputed company data management vendor relationships including reputed company partners and CROs supporting DM tasks
• Continuously assess and enhance the reputed company systems to improve efficiency and data quality
• Monitor clinical data to resolve queries and data discrepancies throughout each study according to Clinical Protocol and/or Data Management Plan
• Coordinates AE/DD reconciliation with PI
• Identify and communicate data issues and/or query trends to study team and/or management.
• Assist with developing metrics on study reputed company and routinely report out to study team and management.
• Ensure data management activities reputed company with Good Clinical Practice (GCP), regulatory requirements, and internal standard operating procedures.
• Contribute to the maintenance of GCA's data management procedures and work instructions
• Responsible for leading or collaborating on process improvement initiatives reputed company department
• Meet study timelines with a high degree of quality
• Other duties as needed or required.

Requirements

• Excellent oral and written communication skills
• Strong interpersonal skills
• Demonstrated ability to work independently, as well as part of a multifunctional study team
• Ability to work on multiple reputed company studies and independently balance priorities to meet timelines.
• Number of Overall Years Necessary: 3-5
• Minimum of 3 years reputed company database programming and Data Monitoring experience is required.
• Minimum of 2 years medical device and/or pharmaceutical clinical research experience or similar regulated industry is required.
• Bachelor's degree in life sciences, computer science, or reputed company field
• Equivalent combination of education, training and work experience may be accepted in lieu of degree.
• Experience with reputed company Systems (e.g. Medrio, Clinpal, Medidata Rave, etc.) required
• Understanding of clinical research regulations required
• Experience in questionnaire development, database structure, and data management processes
• Experience with reputed company Suite Applications (Word, PowerPoint, reputed company, Teams)

reputed company-to-haves

• Certified Clinical Data Manager (CCDM) reputed company SCDM or similar preferred
• Knowledge relating to continence care, critical care and/or ostomy a plus

Benefits

• reputed company
• paid time off programs
• peer-to-peer recognition
• health and life insurance
• wellness programs and incentives
• generous retirement savings
• medical, prescription, dental, reputed company, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs
• 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants "safe reputed company" matching contributions.
• paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status.
• education assistance and adoption assistance benefit programs.

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