Lead Clinical Data Manager

Linical Americas

JOB DETAILS
JOB TYPE
Full-time
POSTED
30+ days ago

Linical is an industry leading, midsized, global contract research organization (CRO) with a significant footprint across North America, Europe, and Asia-Pacific. Linical provides the full spectrum of drug development services from early stage to large-scale, multinational studies. Our areas of expertise include Phase I-IV oncology, vaccine, infectious disease, CNS, and general medicine. Linical is the ideal partner for drug developers looking to expand their program into new markets, combining strong business and operational perspective with clinical and medical expertise. 

We have an exciting career opportunity in the position of Clinical Data Manager/Sr. Clinical Data Manager.  This position is a remote/home based role located anywhere in the USA or Canada.

POSITION DESCRIPTION

The Clinical Data Manager/Senior Clinical Data Manager will lead and/or perform, with quality, all data management activities for one or more projects.  Senior Clinical Data Managers independently lead multiple, high volume and extremely complex studies to deliver accurate, timely, consistent, and quality clinical data.  Clinical Data Managers perform the same study leadership, though the number of projects and/or complexity may be reduced. The role will mentor other staff as well as be responsible for customer contact and Data Management functional, administrative, and financial oversight of projects assigned.

DUTIES AND RESPONSIBILITIES

  • Works with project management to define timelines for assigned studies to ensure critical data management milestones are met
  • Assists in forecasting data management resourcing for assigned studies
  • Performs monthly revenue recognition for data management activities
  • Monitors study progress to ensure data management tasks meet study budget and timelines
  • Represents data management on study teams and client meetings, regularly informs project management and client of overall study status and potential problems
  • Leads a multi-functional project team of biometrics resources including database programmers, clinical data coordinators, and SAS programmers
  • Identifies and implements solutions for study data management issues and concerns, including proactive prevention strategies based on metrics and forecasts
  • Identifies potential out of scope activities to project and functional management and assists with the contract modification process
  • Performs tasks related to all aspects of the data management process from study start through database lock for both paper-based and electronic data capture (EDC) trials
    • Reviews study protocols to determine data management requirements
    • Designs Case Report Forms (eCRF/CRF) to efficiently capture all data required by the protocol
    • Develops study specific Data Management Plan according to established procedures
    • Creates Data Cleaning Plans to ensure the data's integrity and to identify any outlying values
    • Assists in building study databases or facilitates EDC vendor management of database build
    • Performs User Acceptance Testing of EDC databases and validates paper CRF databases
    • Conducts Quality Control review of eCRFs/CRFs, Data Management Plans, Data Cleaning Plans and databases created by other data managers
    • Reviews study database for incomplete data and outstanding data quality issues
    • Works with sites and study monitors to follow up on query responses and errors identified during data cleaning
    • Manages data provided by third-party vendors (e.g., defines data handling conventions, edit checks, quality acceptance and auditing criteria; reconciles external data against the clinical data; resolves data discrepancies between the external data and the clinical data)
    • Performs SAE/ external data reconciliation
    • Directs database quality control process
    • Oversees the coding of clinical data (adverse events, concomitant medications) using standard coding dictionaries
    • Provides database lock per study timeline
  • Follows all Standard Operating Procedures (SOPs) and working practices
  • Participates in the development and maintenance of SOPs and working practices related to data management activities
  • Mentors junior level staff and peers and assigns, reviews and checks the work of others performing similar duties
  • Participates in the identification, review, and evaluation of new data management technologies
  • Participates in Sponsor Face to Face Meetings (Kick-Off Meetings, Investigator Meetings, etc.) and business development opportunities as needed
  • Other duties as assigned

REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in a life science or industry-related field is preferred
  • Excellent working knowledge of ICH, GCP, and FDA guidelines and regulations
  • InForm, Medrio, Medidata RAVE, and/or Viedoc database and Microsoft Project experience preferred

Our employees enjoy a full range of comprehensive benefits to include but are not limited to medical, dental and vision insurance, company paid life insurance, paid holidays, PTO, 401K with employer match, long and short-term disability, and long term career growth and development opportunities. If you have the experience required and are looking to join an energetic and collaborative team, please apply directly to our website at www.linicalamericas.com.

Linical Americas is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. 

 

About the Company

Linical Americas

INDUSTRY
Biotechnology/Pharmaceuticals