Lead Clinical Data Technical Analyst

Posted on Oct 5

Location: Cambridge, MA
Job Type: Contract
Job ID: W4083958

OBJECTIVE:  (Briefly summarize the overall purpose of the position.  Objectives should be written in 3 – 4 statements).
 
  • The purpose of this position is to provide complex program-level data collection and standards compliance expertise and leadership by:
  • Defining and implementing complex data collection and capture strategies to meet the requirements of global development programs.  Position may lead complex projects associated with clinical data collection solutions with various global alliances.
  • Evaluating and leading new technology assessments related to electronic clinical data capture and storage.
  • Responsible for program-level oversight of clinical study EDC designs, integrations and data transfers for complex clinical program data.
  • Implementing and enforcing the standards for the collection, validation and storage of clinical program data to maximize global data integratability and efficiency.
  • Directing the work of vendors globally to provide data capture technologies and programming services to achieve quality, timely, cost-effective study deliverables.
 
ACCOUNTABILITIES:  (Describe the primary duties and responsibilities of the job.  Approximately 5 – 10 task statements should be identified).
  • Represent the Clinical Data Technology function in support of assigned clinical studies and programs.  Independently represents the Clinical Data Technology function in global, cross-functional teams and projects.
  • Provides program-level guidance and oversight for complex electronic data capture and processing strategy including technologies to meet the needs of the project team and maximize global development program data integration.
  • Manage and enforce program-level standards on behalf of Clinical Data Technology to ensure data consistency for all studies in the clinical development program.
  • Evaluate and lead the assessment, definition and implementation of new CDT processes, standards and technology solutions.
  • Collaborate and direct work with vendors globally to provide data capture technologies and programming services to achieve quality, timely, cost-effective study deliverables.
  • Provide technical direction for vendors supporting assigned studies/programs. Review and approve key Clinical Data Technology vendor deliverables.
  • Implement and enforce the global standards to the data collection and dataset deliverables and ensure conformance to standards for assigned clinical studies.   Standards include but are not limited to (e)CRF standards, database (SDTM) specifications, and metadata repository requirements. 
  • Ensure all Clinical Data Technology study deliverables are completed in accordance with the requirements of the data management plan and all applicable Takeda standards.
  • Ensure all Clinical Data Technology study documentation has been appropriately archived in a timely manner.
  • Create and validate custom user reports from data capture reporting tools or data programming tools to facilitate the review of data by cross-functional team members.
  • Generate and quality assure subject electronic case report forms for use in clinical study reports, final study archival, and for archive at study sites.
  • Anticipate and communicate resource and quality issues that may impact deliverables or timelines.  Propose and implement solutions.  Escalate issues to management as appropriate.
  • Manage system upgrades for CDIT technologies, including all required IT documentation.
  • Provide training to new Clinical Data Technology team members.
  • Represent the Clinical Data Technology function on policies, plans and objectives, both internally and at industry meetings.
  • Comply with all applicable regulatory requirements and Takeda standards and procedures.
  • Other duties as assigned.
 
SCOPE OF SUPERVISION:
                                                                  

NUMBER OF EMPLOYEES SUPERVISED

Direct In-Direct
Managers/Supervisors 0 0
Exempt/Professional/Technical 0 0
Non-Exempt 0 0
 
EDUCATION, EXPERIENCE AND SKILLS:  (List the education and experience required to perform the primary responsibilities of the job.  Equivalent combinations of education and experience should be noted).
  • ONE YEAR OF MEDIDATA RAVE BUILD EXPERIENCE REQUIRED!
  • BS/BA required, preferably in a health-related, life science or computer science area and with a minimum of 5 years data management, EDC/database programming and/or clinical development experience;
  • Experience with all phases of development and at least 2 therapeutic areas
  • Advanced knowledge of relational databases (e.g., Oracle-based systems, SAS) and experience using multiple clinical data management systems including EDC.
  •  Advanced knowledge of office software (Microsoft Office).
  • Strong understanding of clinical trial documents (protocols, data management plans, CRFs, study reports) and processes.
  • Advanced knowledge of FDA and ICH regulations including 21 CFR Part 11 and FDA Guidance for Computerized Systems Used in Clinical Trials.
  • General knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes is preferred.
  • Previous experience with EDC study conduct is required.
  • Basic understanding of CDISC standards is preferred.
 
LICENSES/CERTIFICATIONS:
Prefer Certified Clinical Data Manager (CCDM), as administered by the Society for Clinical Data Management (or equivalent professional certification).  Prefer EDC build certification as administered by industry EDC software vendors.
 
PHYSICAL DEMANDS:  (Identify any physical demands required in the performance of the primary responsibilities of the position).
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Ability to sit and stand for long periods of time.
  • Carrying, handling and reaching for objects.
  • Ability to lift and carry over 25 pounds.
  • Manual dexterity to operate office equipment i.e. computers, phones, etc.
 
TRAVEL REQUIREMENTS:
  • Access to transportation to attend various meetings held in proximity to the Takeda offices.
  •  Able to fly to various meetings at investigator, vendor or regulatory agency sites.
  • Some international travel may be required.
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