Data Manager (Contract)

US-NJ-Jersey City
ID
2017-1067
# of Openings
1
Category
Clinical Development

Overview

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

 

Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.

Responsibilities

The Contract Data Manager is responsible for managing all data collection, processing and delivery aspects in the assigned clinical studies.  This includes developing and implementing study-level data management planning to ensure that the outsourced and in-house activities are completed according to the agreed scope, quality standards and timelines.

The Contract Data Manager is responsible for day-to-day coordination of ongoing data management activities acting as data management functional representative in the study team.  Working with internal and external cross-functional teams, the Contract Data Manager will coordinate design, validation, implementation, and maintenance of data acquisition instruments and modalities, validation and finalization of study databases, and preparation of data management deliverables for ongoing data monitoring and for use in the interim and final analyses. This 6-month 40-hour per week contract role, which can be extended up to 18 months, is located at our Jersey City, NJ Headquarters.

 

  • Serve as the subject matter expert on topics related to data management activities. Contributions include, but are not limited to: vendor selection and management, representing data management function in the clinical operation team for the assigned studies, collaboration with MTDA and global data science staff (data management, statistics, clinical pharmacology, programming), collaboration with MTDA Clinical Development staff, cross-functional collaboration with other departments at MTDA and the global organization.
  • Support outsourcing activities by providing input on data-related budget, scope and requirements (e.g. RFP, scope of work, vendor costing, change orders, etc.), vendor selection and management, risk and communication management, and application of best data management practices and regulatory requirements.
  • Coordinate development of study-specific data acquisition solutions (paper and/or electronic) that adhere to the study protocol, the development program, industry regulations/standards, and Company standard procedures. This includes overseeing the specification/design, validation, and implementation, maintenance, decommissioning and archiving steps, relevant planning, quality control and documentation.
  • Manage clinical data processes to ensure integrity and adequate quality of data, including the outsourced or in-house validation and reconciliation of all study data modalities, review of data transfers, data transformation and mapping (specifications and actual data structures), planning and implementation of data quality review.
  • Accountable for data management activities to support the establishment of subject validity and analysis set assignment, including but not limited to the following: specification of programmed protocol deviations, manual data listings, and coordination of in-house interim and final Data Review Meetings, preparation and completion of the associated documentation.
  • Responsible for coordinating routine study-level data management activities in accordance with the study project plan, including but not limited: eCRF and eCOA/ePRO design; system integration, validation and UAT; edit checks; study-specific data management procedures; data management plans and reports: coding of medical terms, SAE and external data reconciliation; query resolution; mapping specifications; completion of data management portion of the trial master file
  • Participate in the development, review and updating of data management SOPs and working practices.
  • Participate in process improvement initiatives.
  • Perform other departmental duties as assigned

Qualifications

  • Bachelor's or Master's degree or equivalent in Natural or Life Sciences, Computer Science, or Medical Informatics.
  • 7 to 10 years of study and/or project level experience as Data Manager in leading roles in pharma or biotech environment and various stages of drug development (Phase I, II, III).
  • Significant experience in using data management technologies (electronic data capture and eCRF, eCOA/ePRO, relational databases, data review and visualization tools).
  • Experience in CDISC data standards (SDTM, ADaM, define.xml). Experience in CDISC validation tools a plus.
  • Experience in outsourcing models.
  • Basic SAS programming knowledge and/or programming, scripting, SQL skills a plus.
  • Knowledge of the drug development process.
  • Demonstrated understanding of regulations and guidelines (e.g. ICH, GCP, FDA guidelines and European Clinical Trials Directive, Privacy rules (HIPPA)).
  • Good general computer skills (Microsoft Office applications, common file formats, etc.).
  • Strong organizational and communication skills and ability to collaborate. effectively with other groups in a matrix organization.
  • Able to collaborate with minimal supervision.
  • Able to concurrently work on several clinical studies.
  • High standards of business conduct and ethics.
  • Ability to sit or stand for long periods of time
  • Manual dexterity required to operate office equipment, i.e. computers, phones, copy machine/printer
  • Ability to carry, handle and reach for objects
  • Ability to lift and pull up to 15 pounds

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed