- The Senior Clinical Data Analyst will interact directly with the Data Management Team Lead and occasionally with Clinical Project Leaders, Medical Directors, Biostatisticians, Statistical Programmers, and Medical Writers. Individuals selected for this role will receive mentoring and oversight support as they transition into an experience where they can offer the same to their peers.
- This opportunity includes oversight for Phase Ib and II Global Oncology studies lasting 2-4 years, allowing full experience from Protocol Review & Database Development through Database Lock. Individuals in this role will gain experience with data deliveries through the life of the trial, including working on submissions to regulatory authorities.
Main Activities Will Include
- Provide data management input on Clinical Trial teams.
- Performs DM activities for the startup of a study including preparing the eCRF, CCGs where needed, Data Handling plan (DHP) Data Review Plan (DRP), and performing user acceptance testing (UAT) as applicable
- Manage local lab setup for the Clinical Database as applicable
- Under supervision ensures consistency of assigned trials with program-level standards
- Understands third-party data requirements and begins to gather an understanding of new technologies that may be used in the course of clinical trials
- Performs ongoing review of all data generated from the clinical study including Third party and local lab data as well as SAE reconciliation where applicable
- Ensures activities that are performed are done with quality and understanding of the process
- Verifies and tracks eCRF completion including Query resolution and provides data status updates as needed
- With support from the Trial Data Manager develops proposals to resolve issues that may occur during the running of assigned trials.
- With support from the Trial Data Manager gives input into Study Specification worksheets should assign trials to need to be outsourced.
- Has a working knowledge of FDA and ICH guidelines.
Ideal Candidate Will Possess
- Experience in clinical research (Pharma/CRO).
- Bachelor’s degree as a minimum.
- Proven ability to lead and collaborate with global and cross-functional teams - the ability to coordinate & prioritize tasks for the DM operational and programming teams (when) in the Senior CDA role.
- Ability to independently interact with Sponsor liaison to discuss data issues/project data validation requirements, as needed.
- Experience and understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards.
- Excellent interpersonal, verbal, and written communication skills.
- Knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG).
- Robust knowledge of ICH-GCP Guidelines.
- Good knowledge of EDC systems (e.g. DataLabs, Rave.).
- Good knowledge of electronic source data capture systems (e.g. ClinBase).
- Good knowledge of all DB set-up activities including but not limited to Database Configuration Specifications, and Data Validation.
- Fluent in English.
- Basic knowledge of SAS.
About the company
PAREXEL provides biopharmaceutical services and conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval process.