We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.
This position is responsible for managing all activities associated with the data management process throughout a clinical trial and overall quality and integrity of data input and output. This position reports to the Functional Head of Data Management.
- Key point of contact for the sponsor and the study team on all study data management activities.
- Create and adhere to timelines in the implementation of study tasks, ensure all work performed is of high quality, compliant with Good Clinical Practice (GCP), ICH Guidelines and all applicable laws and regulations.
- Proficient with Electronic Data Capture (EDC) systems, such as Medidata Rave and Oracle Inform. Able to adapt knowledge to other EDC platforms as needed.
- Read and understand each assigned oncology protocol.
- Develop project specific clinical database specification as needed. Work with Database Programmer, Project Manager, and Sponsor on creation of unusual and dynamic database forms. Participate in and ensure a quality database design.
- Lead the development of Data Validation Specifications (DVS) for robust edit check programming and testing of the clinical database.
- Perform User Acceptance Testing (UAT) including validating data entry screens and testing edit checks. Report errors to the database programmer and assist them in making appropriate corrections.
- Generate data management documents appropriate for the clinical trial, including but not limited to the Case Report Form (CRF), Data Management Plan (DMP), CRF Completion Guidelines (CCG), and Data Validation Specification (DVS).
- Work with the Sponsor and third-party vendors to create Data Transfer Specifications (DTS) for transfer of external data.
- Perform data reconciliation, including adverse event (AE), serious adverse event (SAE) and external lab data reconciliation.
- Develop and generate data reports from EDC systems which details the progress of the study and help in identifying the study related data issues and report trends.
- Develop and generate data reports from EDC systems for medical meetings such as safety review meetings and dose escalation meetings. This includes generating patient profile reports and aggregate data listing.
- Perform medical coding of terms and medications using medical dictionaries such as WHODrug and MedDRA.
- Manage the medical dictionary licensing process.
- Work with clinical trial site staff, investigators, and Clinical Research Associates on review of the study database entries, data query and query resolution.
- Ensure clean and valid clinical study data for delivery to biostatistics through involvement in all phases of global clinical study data management process from study start up to database lock.
- Work with the assigned Clinical Data Associate(s) to perform delegated DM tasks.
- Generate study metrics as needed for financial revenue recognition.
- Prepare, review and submit appropriate data management documents for upload to the Trial Master File.
- Perform other related duties as assigned.
- This position requires at least a Bachelor's degree preferred in a health science field, and at least 4 years of data management experience in a biotechnology/pharmaceutical setting, preferably with experience in Phase 1 and 2 oncology research trials.
Required Specialized/Technical Skills:
- Understanding of Phase 1 and 2 oncology clinical trials
- Certified/trained and/or familiar with commercial electronic data capture systems (EDC) such as Medidata RAVE and Oracle Inform.
- Broad familiarity in all aspects of clinical trial research, including FDA, GCP/ICH guidelines, CDISC/CDASH, SDTM standards and 21 CFR part 11.
- Trained in Good Clinical Practices (GCP)
- Experience with hands-on management of clinical databases, including database design, data entry, query management and data reporting.
- Demonstrated skill with establishing and documenting standard processes by which project tracking data is collected, updated and reported to the project team
- Excellent communication, written and interpersonal skills
- Strong ability to perform individually and as a part of a team
- Client focused approach to work
- Strong computer skills, including Microsoft Excel and Word. Experience with Microsoft Project preferred.
- Ability to train and lead the work of others
- Possess strategic thinking, contingency planning, problem-solving and dispute resolution skills
- Ability to quickly find common ground and solve problems
- Excellent planning and organizational skills
- Strong knowledge of the clinical drug development process
TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.