The posting
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities:
Data Validation (cleaning)
- Lead/Responsible for data validation (cleaning/review/reconciliation) activities during conduct and database lock (Primary CDA), e.g. query management, manual/SAS listing reviews and external vendor data reconciliation.
- Highlight issues/risks to delivery by understanding interdependencies - support mitigations as part of Risk Management Plan.
Data Management Documents/Plans (Trial Master File)
- Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines.
Study Start-Up Activities and User Acceptance Testing (UAT)
- Lead/perform user acceptance testing on clinical database setups.
- Review protocols and EDC Entry Screens if required.
- Provide input on the data management timelines and coordinate the DM operational activities during database set up.
Data Tracking and Entry
- Track and review CRFs. Support data entry where required.
Project Quality Management & Compliance
- Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
- Perform/Lead functional QC activities on databases and/or patient data, as per business needs.
Training
- Maintain training compliance as per Job Roles assigned, including On-the-Job training.
- Address training needs, as per Development Goal/s identified.
- Provide relevant on-the-job training to staff and project teams as appropriate.
- Act as Mentor for other clinical data analysts.
- Act as Subject Matter Expert regarding DM operational tasks/tools/processes/systems.
Process/Project Improvement
- Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies.
Project Finance & Resource Support
- Determine root cause of operations-related project variance in a timely manner, based on DM operational metrics/labor hour reports - provide input on Changes in Scope needed.
Skills:
- Ability to lead and collaborate with global teams - ability to coordinate & prioritize tasks for the DM operational team when in the Primary CDA role.
- Ability to independently interact with Sponsor liaison to discuss data issues/project data validation requirements, as needed.
- Negotiation skills and ability to influence in order to achieve mutually beneficial results.
- Strong problem-solving skills and logical reasoning, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses.
- Commitment to first time quality, including a methodical, analytical and accurate approach to work activities (attention to detail).
- Time management and prioritization skills with a sense of urgency - in order to meet objectives.
- Strong interpersonal, oral and written communication skills - using concise phrasing tailored for the audience with a diplomatic approach.
- Basic presentation skills.
- Strong learning ability and knowledge sharing approach; swift understanding of technologies and new processes.
- A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing technical environments.
- Evidence of accountability relative to Key Accountabilities in Job Description.
- Written and oral fluency in English.
Knowledge and Experience:
- Advanced technical aptitude with awareness/potential prior experience in Microsoft Office Products (strong computer skills).
- Advanced understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock)
- Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOPs and study specific procedures
- Strong knowledge of Clinical Data Management Systems and proficiency in at least one system (e.g. InForm, Rave, Veeva, Data Labs, ClinBase.)
- Good understanding of Clinical Study Team roles within Data Management - awareness of DML activities e.g.: budget reviews, resource forecast, etc.
- Experience in clinical research industry
- Good knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG)
- Advanced knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out
- Advanced knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data Validation
- Basic knowledge of SAS (programmed listings)
- Basic knowledge of Data standards (CDISC)
- Basic understanding/willingness to learn of financial principles/drivers for management of DM project financials with regards to forecasting and scope of work.
- Experience of leading virtual Data Management operational team to perform DB set up, data cleaning activities
Education:
- Bachelor’s degree and / or other medical qualifications or relevant industry experience.
