Anna Wójciuk

Applies data management expertise and computer skills in support of the data management activities of drug and vaccine development programs. Responsible for managing central and local laboratory data; designing and managing case report form (CRF. eCRF) clinical data in accordance to industry standards (e.g. CDISC/CDASH); assessing data quality; performing manual term encoding; providing study specific documentation based on internal standard operating procedures; interacting effectively and working closely with people across functional areas within the organization as well as global customers and vendor partner. As a Biometrics Team Leader holds also staff management responsibilities.

• Coordinates and performs the collection and processing of CRF data • Performs data management activities following Clinical Data Management SOP and ICH/GCP practices • Encodes unrecognized terminology entered into the database using MedDRA and other dictionaries, resolves encoding data discrepancies, and supports re-encoding of terminology due to vocabulary updates • Coordinates the collection and processing of laboratory data • Supports user acceptance testing activities of Clinical Data Management tools • Supports in creation/updating of SOPs.

Job description: • Building relationships with investigators and site staff remotely • Ensuring compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOP and study specific procedures • Creating and distributing study document • Initial and ongoing drug / supply management • Determining the completeness and quality of the in-house site specific files • Reviewing and updating all relevant tracking system on an ongoing basis • Collecting updated /amended regulatory documents in collaboration with CRA and CTS • Reviewing recruitment plans and supporting sites in enrolling patients • Following-up on data entry, query status and SAEs • Reviewing site payment status.