Jobs at Parexel
We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.
Clinical Data Analyst (FSP), South AfricaJob ID 81753BR South Africa, Remote
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.
The Functional Service Provider (FSP) division of Parexel is seeking a candidate for a Senior, hands-on Data Manager role. This individual will work with the Clinical Trial Team at a Top 5 Pharma company, behaving as if they are employed directly at this Pharma. The Senior Data Manager 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 in 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 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 set up 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 assigned trials 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 - 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, Data Validation.
Basic knowledge of SAS.
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