Description of Position:
This position will lead clinical data management activities for programs or projects, representing clinical data management function on internal and external teams. This position is also responsible for the oversight and quality check of the clinical data management tasks performed by a CRO, coordination of internal cross-functional team data review activities to the issue resolutions, to ensure the data deliverables with good quality and within thew expected timelines for statistical analysis, publications and regulatory reports/submissions.
Reporting to the Senior Director, Data Management, this position may assists in the developing SOP, working instruction, job aid etc. to align with the corporate strategic plan for the clinical data management department.
Responsibilities:
• Lead data management efforts to coordinate study from start-up activities, interim data cuts to support various activities, to close out activies
• Represent data management function at cross-functional meetings
• Lead regular data review meetings in a cross-functional team environment.
• Responsible for data cleaning, query and resolutions, review of medical coding
• Oversee or responsible for external lab data reconciliation, manage and reconcile external data, authoring data transfer agreements
• Lead or oversee database lock activities and ultimate archiving of study data
• Supervise and mentor supporting data managers to ensure data management activities are conducted as expected
• Lead eCRF development and facilitate cross-functional reviews of specification
• Oversee and direct database building activities, including review of edit check specifications, lead and perform the user acceptance testing
• Monitor data collection, data cuts, coding, and cleaning by CROs through tracking of study metrics and targeted data reviews
• Review data management plans, CRF completion guidelines, external data transfer specifications and other study documentation, ensuring all data management documents are completed and to be filed in the study eTMF and are ready for regulatory inspection
• Using data visualization tools to perform data review or quality check data with cross function teams
• Review clinical study protocols and statistical analysis plans
• Participates in other activities and meetings to support Data Management/Biometrics as necessary
• Support in the SOP's, working instruction, templates development for data management head of the Data Management
Minimum Requirements:
• Excellent interpersonal skills and good conflict management and negotiation skills
• B.S. / B.A. in scientific discipline (minimum undergraduate degree required), with 7 years of Data Management experience and a minimum of 4 years of leading or vendor oversight experience
• Experience with medical dictionaries, including MedDRA and WHODrug
• Proficient with electronic data capture (EDC) systems like Veeva EDC, Medidata-RAVE and the development of CRF/eCRF for clinical trials and its impact in database design/development
• Proficient experience working in an outsourced data management model.
• Excellent verbal and written communication, organization and time management skills
$171,000 - $201,300 a year
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
