An opportunity to join an Oncology focused full-service clinical CRO and consultancy optimized to the needs of small to mid-market biotech. They brings expertise from site-level, biotech, and CRO roles, all with the common goal of improving the product development experience for all stakeholders.
You'll be working closely with the COO, providing input on key processes and any necessary infrastructure to ensure proper oversight and be responsible for managing and overseeing all CDM activities as well as supporting cross functional teams to deliver quality projects for all phases of clinical trials and programs.
Responsibilities:
Serves as the data management subject matter expert, overseeing all aspects of clinical data management across all trials and all clients, ensuring adherence to timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines.
Promotes standardization, automation, innovation, process improvement, and technology enhancement in CDM and beyond to increase drug development efficiency.
Ensures that Data Management Plans (DMPs) are consistent and regulatory compliant across studies and programs (inclusive of Case Report Form (CRF), CRF completion guidelines, SAS annotated CRFs, data handling plan, data entry review guidelines, edit check specifications, data transfer specifications, and database audit plan).
Reviews and provide input into protocols, SAP, IB, CSR and other clinical study documents during development.
Function as internal DM Study lead and overseeing all data management activities including generation and review of metric status and patient tracking reports.
Requirements:
10 year's in a clinical data manager role, with significant CRO experience.
2+ years experience leading a data management team.
BSc/MSc in science, health, or similar subject.
Experience managing DM activities for Phase I through III studies, experience in oncology clinical trials and early phase is critical.
Strong EDC skills, including Medidata Rave.
Expertise in clinical oncology indications, end points, data flow, data integrity, standards and data quality.
Familiarity with data standards, such as CDASH, CDISC, ADaM) and understanding of GCP/ICH and applicable regulations.
Registration (BLA/NDA/MAA) submission experience highly desired.
