CRC Oncology is recruiting a bilingual (EN/CN) Senior Clinical Data Manager (CDM). Under the direction of the Director, Clinical Data Management, is responsible for the daily clinical data management operations of studies managed. The Senior Clinical Data Manager will concentrate on good data management documentation practices and apply applicable company standard operation procedures (SOP) to provide excellent service to our sponsors. Higher level CDMs will also mentor lower level staff. Performs duties in accordance with company’s values, policies, and procedures.
• Leads the process of Electronic Case Report Form (eCRF) development for a study. Designs and tests studies in company data management system.
• Manages workload for 3 to 4 single-site and/or full scope CRO trials, or a combination of single or multiple site CRO projects.
• Leads the development and maintenance of the Data Management Plan (DMP).
• Creates study-specific data entry instructions and conventions.
• Creates and maintains the data validation specifications.
• Designs edit checks within the company data management system that conform to the data validation specifications.
• Performs discrepancy management within the company data management system.
• Routinely reviews data issues with internal site staff and assists Data Entry Associates with updates according to discrepancy responses to maintain a clean database.
• Develops data listings and reports from the data management system and performs trend analysis to inform data review, using tools such as Smart Reports in the EDC.
• Creates and maintains study status reports for tracking eCRF completion, discrepancy management, and other study metrics as needed.
• Performs medical coding of adverse events and concomitant medications.
• Manages and QCs data received from external vendors.
• Prepares and QCs internally generated data for review by CRAs or the project manager, and for transfer to clients.
• Supports the Director, Clinical Data Management, in the oversight of CROs or third-party vendors for any outsourced studies.
• Attends team meetings as needed to represent CDM interests.
• Reviews protocols and provides input relevant to data management issues.
• Provides input for the development of project specific timelines and budgets.
• Trains on department specific Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Manages workload for 3 to 4 full scope CRO trials, including multi-site projects, or a combination of single or multiple site CRO projects.
• As directed, oversees the projects of other CDMs and mentors as needed.
• Develops and maintains CDM procedures, standards, and practices.
• Oversees third party vendors for any outsourced studies, including biostatistics vendors, and assists in relationship management.
• Assists in creating budget estimates for potential studies and providing proposal input to Budgeting and Contracting.
• Assists department head in resource and project planning.
• Assists department head with overall key performance indicators and metrics analyses.
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Senior CDM Education and Experience
Bachelor’s degree in life sciences or mathematics and/or formal or on-the-job training in clinical trial methodology and Good Clinical Practice (GCP) plus five or more years of experience in direct data management experience at a CRO and obtained Certified Clinical Data Manager (CCDM) status, or seven or more years of experience without CCDM. Experience writing SOPs and training documentation and mentoring data management staff. Experience using visual analytics and business intelligence tools for performance monitoring. Experience with randomization and inventory systems (e.g., IWRS) to lead technical oversight. Demonstrated use of project management tools and skillsets.
Skills, Knowledge and Abilities
Technical competency using data management systems, especially EDC systems. Understanding of US and international regulatory mandates and guidance for clinical research including FDA/ICH-GCP. Demonstrated ability to manage a complex workload and prioritize tasks based on program goals. Ability to work quickly and independently and as a strong team player.
Certificates and Licenses
Certificate in building EDC systems preferred. CCDM strongly preferred.
Ability to read and interpret documents such as SOP’s, WI’s, procedural manuals, governmental and clinical regulations, and similar documents. Excellent oral, written and interpersonal communication skills with the ability to communicate effectively to employees and Management groups and in group meeting settings in both English and Chinese.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
To perform this job successfully, an individual should have intermediate knowledge of the current MS Office Suite.
• Clinical Research, Data Management