Lead Data Manager

Summary of The Position:

The Lead Data Manager will manage clinical data related to clinical projects undertaken by FHI Clinical in accordance with the relevant trial protocol and other trial-related documentation, ICH GCP (and local adaptations thereof), local legal requirements, relevant FDA, EMA, and other international guidelines, as well as applicable procedural documents. The Lead Data Manager will communicate with team members regarding data management related to trial data quality and timelines.

Essential Functions:

• Draft/Provide input into/assist with:
  • Data management plans;
  • Case report form design and quality control review;
  • Database design and testing;
  • Edit checks and the validation of these;
  • Coding of data using standard coding dictionaries, where applicable;
  • User Acceptance Testing as and when required;
  • Data handling reports;
  • Data cleaning, including manual review, reconciliation and query generation and resolution;
  • Prepare and maintain all data management documentation, including reports, governing data management processes as and when required.
• Ensure that service and quality meet the specifications delineated in the Procedural Documents, data management plan, and scope of work.
• Assist the Senior/Lead Data Manager with delegated tasks and responsibilities, including, but not limited to, support in preparing and reviewing Procedural Documents and filing and maintaining clinical trial documents in the designated sections of the Trial Master Files.
• Any other duties and responsibilities that may be assigned occasionally.

Knowledge, Skills, and Abilities:

• Effective oral and written communication skills in English.
• Excellent organization and planning ability.
• Uncompromising attention to detail and the ability to think analytically.
• Computer skills and the ability to acquire proficiency with appropriate software packages.
• Good interpersonal skills.
• Proficient knowledge of international and local regulations and guidelines applicable to clinical research, in particular those relating to clinical data management.

Position Requirements

Education: A minimum higher education certificate is required. A graduate or postgraduate in the field of Science or Biotechnology is preferred. Additional relevant qualifications and/or professional certifications in the field of clinical data management would be an advantage.

Preferred Job-related Experience: At least two to three years of data management experience in a clinical research setting is required.

Additional Eligibility Qualifications: Training and demonstrated proficiency in good clinical data management practices.

Preferences: Must have effective oral and written communication skills in English.

Special Position Requirements: Proficiency in Oracle SQL, Siebel Clinical (CTMS) or similar systems will be advantages.

Physical Expectations:

• Typical office environment.
• Ability to sit and stand for extended periods of time.
• Ability to lift or move 5-15 lbs. or 2.26 – 6.8kg.

Travel Requirements:

Expected travel time is less than 10 % for this position.

This job description is not intended to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.

FHI Clinical, Inc. and its subsidiary and affiliate companies provide equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.