BA or BS with a minimum of 4 years relevant experience
Familiarity with Clinical EDC systems like Medidata Rave or Veeva EDC
Experience in managing Lab Data (PK, PD, Biomarkers)
In-depth knowledge of GCP, CDISC standards, FDA/ICH guidelines, and GCDMP
Strong clinical research knowledge with an oncology focus preferred
Proficiency in understanding DM lifecycle for P1-P3 studies
Demonstrated project management skills and ability to handle multiple projects
Strong verbal and written communication, coupled with excellent organizational abilities
Experience in vendor/CRO management and specifications writing
Responsibilities
Lead all Data Management (DM) lifecycle activities from start-up to close-out.
Develop various DM documents tailored to study needs, utilizing templates as a foundation.
Conduct independent data cleaning activities, gathering cross-functional input for custom data review plans.
Oversee management of data deliverables and database locks ensuring quality and efficiency.
Build collaborative relationships with various study team representatives across disciplines.
Ensure timely completion of data management deliverables using available metrics and resources.
Manage and coordinate vendor and CRO work, ensuring quality outcomes.
Benefits
Opportunity to work with a diverse team of scientific professionals
Engage in various stages of the clinical trial process
Professional development opportunities within a cutting-edge field
Access to advanced technologies and methodologies
Collaborative work environment fostering innovation and teamwork
Full Job Description
Responsibilities:
Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out.
Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans. Utilize templates and standard guidelines to initiate documents, but demonstrate critical thinking, alignment-building and discretion to tailor documents to study needs.
Independently lead data cleaning activities such as, but not limited to, study team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation. Gather cross-functional input to drive creation of custom data review plans. Evaluate options and exercise discretion to choose efficient and effective issues resolution paths.
Manage data deliverables processes and database locks, with high quality and efficiency.
Foster collaboration and relationship-building with all study team representatives (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Scientists, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics Scientists, Medical Writers, Regulatory representatives, etc.)
DM Project Management: With oversight, ensure data management deliverables are met on time. Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities. Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables. Provide solutions for data management issues that arise during study conduct.
Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product. Assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits)
Performs Medical Coding as needed, works with CROs, Medical Monitors, and Clinical Scientists to coordinate activities for the medical review of clinical trial data.
Run SAS and/or R programs, review SAS and/or R logs, troubleshoot errors, and generate output. Program SAS and/or R Non-System Edit Checks/Back-end checks and SAS and/or R Data Listings as appropriate for skill level.
Evaluate CDM processes and applications for improvements; participate in working groups to develop and implement new processes and applications.
Participate in development of DM specific SOPs.
Responsible for oversight of CRO data management activities and integrating the various functional group input.
ll other duties as assigned.
Requirements:
BA or BS and a minimum of 4 years of relevant experience.
Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession.
Experience working within a Clinical EDC system (e.g., Medidata Rave, Veeva EDC).
Experience with managing Lab Data, such as PK, PD, and Biomarkers.
Detail-oriented; performs quality and accurate work.
Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and GCDMP.
Strong knowledge of clinical research, drug development process, and medical terminology, oncology experience preferred.
Knowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials.
Knowledge of MedDRA and WHO Drug coding.
Project Management skills, ability to manage multiple projects and meet deadlines.
Strong interpersonal, organizational, and communication skills.
Prior experience writing specification documents and/or work instructions.
