Manager, Clinical Data Management

Key Responsibilities

• Manage and monitor the progress of data management activities with CRO(s) or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts.
• Ability to manage track and oversee CRO responsibilities for overall performance management and provide updates to Head of Data Management.
• Able to guide and influence team members on data management principles and database management principles, vision and strategy.
• Able to perform independently and/or oversee and be accountable for Data Capture (EDC) systems testing, upgrades, migrations, report production and query management and or CRO (in collaboration with lead data manager) according to company standards.
• Participate in clinical study teleconferences and in person meetings to represent data management and provide respective study updates.
• Review protocol(s) to ensure appropriate data points are captured within the electronic Case Report Forms (eCRFs) for study conduct, metric development, and trend monitoring in support technology.
• Create, update, and issue data management study specific documentation in line with study activities.
• Manage study build process including writing, proofing and assisting with data build specifications.
• Extract and analyze clinical data using data visualization tools, SAS data listings and or other outputs regularly to identify trends and/or issues to be communicated and addressed with CRO to support IMC study oversight of CRO activities for regulatory compliance.
• Manage, participate and be accountable for the work responsibility deliverables of the assigned DM study team.
• Submit and manage study escalations related to poor vendor performance.
• Provide site and/or study team training.
• Develop, deploy and manage a be accountable for EDC timelines for milestone data deliveries.
• Oversee study review practices for study team adherence.
• Aid or provide training to internal study team members on Agiloft and/or Netsuite processes.
• Responsible for department processing of contracts and invoices.
• Perform occasional data review activities of clinical data and/or external data, to help support lead data manager in high quality oversight of data cleanliness and associated activities.
• Lead the data management oversight of the TMF, with the CTM, maintenance of data management files and perform consistent quality checks of the TMF to ensure data management related documents are filed in a timely manner to maintain regulatory compliance.
• Assist in the database lock and freeze activities per SOPs and timelines.
• Develop or assist with the development of workflow processes and work instructions, improving the efficiency of data management activities at IMC.
• Other duties as assigned

Education, Experience and Knowledge

• Education & Qualifications: BA/BS, preferably in the scientific/healthcare field. At least 5 years of directly relevant work experience.
• Experience & Knowledge: Significant track record in Data Management for the pharmaceutical/biotechnology industry, or CRO, as a Lead Clinical Data Manger. Good project management skills and a proven ability to multitask. Comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice. Attention to detail and the ability to work independently and/or within a multi-disciplinary team, as well as with external partners and vendors. Experience and understanding of the Oncology therapeutic area and with Phase III and/or Pivotal studies are preferred. Solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems. Experience with Medidata RAVE is preferred.

US Salary Range

$107,250 to $178,750