Clinical Data Manager
January 16, 2020
Department: Clinical Affairs
Reports To: Director, Clinical Research
FLSA Status: Exempt
The Clinical Data Manager is an enthusiastic and hands on person, who is responsible for the coordination and management of planning, reviewing, and cleaning clinical trials data and/or clinical development data.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Data Oversight for Projects/Programs
- Data representation for internal/client team meetings and communication
- Provides Metric reports for internal/external project teams
- Develop and propose process or system improvements for global implementation
- Review team member activities and deliverables to ensure plans and processes are followed
- Provide open environment for question/issues about DM topics
- Design and modify eCRFs and EDC edit checks
- Responsible for building, review and validation of clinical database
- Create and maintain project DM documentations
- Extract and monitor the trial data to identify issues
- Work with CRAs to review data and highlight inconsistencies
- Oversee System Development and modifications:
- Review the CRF design, annotated CRFs, edit check specification and DM listings
- Assist clinical team to facilitate clinical team review of system and/or specifications (Online Screen Review, Edit Check Review, Data Review Plan review, etc.)
- Ensure all non-DM activities related to database development are completed in a timely manner
- Ensure all database modifications are communicated with team and implemented effectively
- Review database developments to ensure standard implementations across studies
- Oversee Database lock activities:
- Facilitate final team review of data and review documentation for database locks
- Ensure comments from internal/sponsor for discussion are documented
- Ensure all non-DM activities related to database lock are completed in a timely manner
- Create and Maintain documentation for templates (DMP, CRF Completion guidelines, Trial Design Document, Edit specifications, Reconciliation guidelines, Report specifications)
- Train others on specific departmental processes (Trial design document creation, Edit Check creation, change control process, database lock, etc.)
The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.
- This position may interact with all departments within the company as well as outside vendors and regulatory agencies.
EDUCATION & EXPERIENCE REQUIREMENTS:
- Bachelor’s degree, preferred in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) required.
- Successful completion of ICH/GCP course
- Research Professional Certification- (CCRA, ACRP-CP) or exam eligibility desired
- BS degree required, preferred in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) required.
- 2+ years related clinical trials data management experience as a clinical trial professional.
- Strong knowledge of clinical operations and the regulatory process.
- Knowledge of molecular diagnostics
KNOWLEDGE, SKILLS AND ABILITIES (KSA’S)
Specific Knowledge Required:
Knowledge: Comprehension of a body of information acquired by experience or study.
Skill: A present, observable competence to perform a learned activity.
Ability: Competence to perform an observable behavior.
- Demonstrated ability to work in cross-functional, multicultural and international teams.
- Excellent communication, organization and tracking skills; project management experience desirable.
- Working knowledge of scientific principles and medical terminology.
- Oncology knowledge.
- A thorough understanding of clinical research methodology including study design, concept development, protocol writing and preparation and knowledge of GCP and local regulatory requirements.
- Solid teamwork, organizational, interpersonal, and problem solving skills; exercises good judgment with respect to Agendia’s confidential information and strategies.
- Demonstrated ability to accurately and effectively evaluate medical/scientific literature and apply this knowledge to study design. Basic understanding of medical aspects of interventional therapies along with willingness to develop in-depth expertise.
- Ability to travel both for day trip and up to several nights at a time for up to 20%
BEHAVIOURAL COMPETENCIES/DESIRED SKILLS
- Ability to multi-task
- Result – and customer orientation
- Quality oriented and results focused
- Can do-attitude
- Establishes ADA (Americans with Disabilities Act) requirements
Working conditions (inside or outside the office).
- Regularly walks, stands, and sits
- Regularly works on a computer for approximately 6-8 hours a day
- Regularly works with pipettes (or other equipment and tools)
- Frequently lifts, pushes/pull, and carries up to 20 pounds
- Exposed to extreme cold for typically 2 hours per month when assisting with removing samples from freezers or loading inventory
- Exposed to hazardous materials (dry ice) on a monthly basis
- Must follow lab safety practices when working in freezer or with hazardous materials including use of personal protective equipment such as: gloves, lab coats, and safety glasses
- Must be able to read and understand scientific and complex directions
- Ability to drive/fly routinely including overnight visits – 35%