Clinical Data Manager I

Position: Clincal Data Manager

Department: Statistics & Data Management

Reports to: Head, Statistics & Data Management

SUMMARY AND DETAILS OF POSITION

Responsible for collecting data from clinical trials created for pharmaceuticals, biologics, or devices. Ensures data collected is complete, reliable, processed correctly, accurate, groups data properly, solves operational problems, and prepares statistic

Principal Responsibilities

• Collaborate with multidisciplinary stakeholders (data entry personnel, biostatisticians, programmers, internal study team, clinical operations, safety monitoring, regulatory) in developing the database design using medical and technical expertise
• Capture and document stakeholder requirements for new/revised data instruments
• Establish and maintain a library of standard forms and associated edit checks
• Prioritize work in line with project management decisions.
• Design clear and easy to follow CRF (new and revised) to collect data specified by the protocol following ICH Guideline for Good Clinical Practice and SCDM GCDMP, data standards, sponsor SOPs, and under guidance of study management team.
• Check CRFs for consistency and adequacy and with safety and efficacy endpoints in mind. Ensure all key endpoints are collected.
• Develop CRF annotations and data specifications per standards required by regulatory agencies in the country where the study is conducted (e.g. CDISC Study Data Tabulation Model for FDA submission, ISO for clinical research, ICH).
• Participate on a team performing user acceptance testing (UAT) of revised/new eCRFs
• Develop the Data Management Plan (DMP) in collaboration with all stakeholders, all applicable regulatory guidelines or local laws, and SOPs of sponsor.
• Ensure the DMP and CRF completion guidelines for each study is kept current with protocol/consent updates, and that all personnel agree to changes and are trained
• Create edit check specifications (data validation plan) based on the DMP, study protocol, annotated CRFs and database design documentation, standard edit check macros, biostatisticians, programmers, and study personnel.
• Test, validate, and document new and revised edit checks; train all relevant personnel on edit checks
• Implement integrated risk based strategy for data cleaning and the design and programming of Clinical Databases.
• Review and approve design, data review ground rules and database design according to Standard Operating procedures and protocol.
• Consult with other employees to solve operational or data problems for clinical trials.
• Provide data entry, transcription, coding, and collating searches where required.
• Manage clinical trials through review, computerization, cleaning and auditing of Clinical Data and databases in compliance with standard operating procedures and regulatory agency guidelines.
• Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines.
• Uphold and enforce data privacy of participants as described in the current IRB approved protocol and informed consent, and relevant government regulations
• Generate data retrievals and summaries.
• Data integrations
• Query management
• Query data inconsistencies and revise case report forms in compliance with standard operating procedures (SOPs).
• External data transfer & reconciliation (including safety data) using ODM
• Custom status reports development
• Develop CDASH and LAB compliant deliverables; update CDASH therapeutic area-specific data collection fields as necessary;
• Consulted for mapping/harmonizing CDASH to SDTM submission structure
• Configure and verify electronic Patient Reported Outcomes (ePROs) created by independent source in OpenClinica Participate module or similar system
• Collaborate with team members for final intake and archival of CDM deliverables, including information technology (IT), legal, and regulatory operations, as well as external vendors.
• Follow best practices, standards, and procedures to close out an EDC study, including final source document review, database locks, audits, media generation, and hardware disposal (the later with support from IT).

Skills/Competencies

• Review Clinical Data on an ongoing basis to ensure quality data
• Drive trial start up and close out activities
• Participate on trial project team to review new and revised trial design and documentation
• Post queries and follow to resolution
• Develop and run data review reports
• Provide study level metrics relating to eCRFs reviewed, Query status, Data Entry and Monitoring Status
• Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.
• Experience with configuring eCRFs in a compliant Electronic Data Capture system such as OpenClinica v3.0 or v4.0, or similar EDC technology

Preferred Education and Experience

• 5+ years of experience in clinical trial data management for confirmatory drug trials.
• Demonstrated knowledge of FDA and GCP guidelines and regulations covering clinical trials, statistics, and data management
• Experience with EDC systems including study start up, conduct data review and database lock
• Experience managing Clinical Data management deliverables for regulatory filings
• Oncology data review experience preferred
• Certified Clinical Data Manager (CCDM) preferred
• Excellent verbal and written communication skills
• Team player eager to drive innovative solutions

Disclaimer: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.