Clinical Data Manager
Here at Tizona Therapeutics, we value Patients First!
With this goal in mind, Tizona develops next-generation immunotherapies.
The successful development of immunotherapies represents one of the most important and exciting breakthroughs in cancer. Despite the recent progress in the field of immuno-oncology, existing immunotherapies are only effective in a relatively small number of patients and types of cancer – a limitation that we hope to overcome.
Tizona’s therapies are designed to modulate the activity of immunosuppressive cells by targeting the cell types and biological mechanisms responsible for immune suppression in the tumor microenvironment.
General Position Overview:
Reporting into the VP of Clinical Development, the Clinical Data Manager will oversee all clinical data management activities for one or more of Tizona’s clinical programs. The ideal candidate will provide input in protocol design and influences CRF design for data collection efficiency to only collect patient data defined in the study protocol(s). Clinical trial database completion, consistency and of the highest quality is a paramount responsibility. The Clinical Data Manager will contribute proactively to the evaluation and reporting of safety data and will be expected to cultivate innovative concepts and ideas that can be tested in formation of new processes and systems to support a clean and precise management of clinical data.
The Clinical Data Manager is a vital part of the Clinical Study Team and closely collaborates with other team members, Tizona colleagues, consultants and CROs. The Clinical Data Manager will be accountable to work with cross-functional team members to ensure high quality data collection, data review and reporting.
Essential/Primary Duties, Functions and Responsibilities:
- Principal oversight of the delivery by data management consultants and DM staff at CROs.
- Provides leadership and technical data management input.
- Works closely with CRO data management group, clinical operations, and clinical development.
- Represents data management at internal Study and Program Meetings.
- Keeps team members and senior management fully appraised of clinical data management issues on Tizona studies in a timely and professional manner.
- Project Management Adherence to Tizona’s SOPs and Policies.
- Serves as contact point for other departments and external contacts (e.g., CROs) on project data management issues as required.
- Coordinates contributions to, provides input and oversees quality of data management documentation (Data Management Plan, Annotated CRFs, CRF Completion Guidelines et al) Study Management Maintains protocol level documentation of data management activities.
- Reviews draft protocol to ensure that the data collection, databasing and reporting requirements can be met.
- Plays a leading role in the design/review of the case report form (eCRF). Provides input into CRF completion instructions.
- Co-ordinates User Acceptance Test (UAT) activities for all clinical databases created and updated.
- Liaises with the CRO data management team to define and implement edit checks on the data.
- Tracks and monitor the flow of the data from the site to the database and develops and distributes clinical data management Key Performance Indicators/Metrics (KPIs) to study team members, as needed.
- Carries out appropriate computer assisted and manual reviews of the database to identify data quality issues.
- Issues data queries related to data quality, track and apply resolutions to the database.
- Produces and reviews data listings and ad hoc data summaries and listings of the data as required.
- Performs review and appropriate quality checks of data presentations (TLGs) Supports and responds appropriately to any audit (notably on clinical data management process or products), internal or external.
- Process Development Develops processes for new initiatives and refine existing processes related to data management.
- Participates in SOP development, training, process mapping, implementation of standardized work processes and other departmental activities.
Skills and Qualifications:
- Experience in oncology clinical trials especially in solid tumors – IE. RECIST criteria, management of AE data procurement from CRF to data entry and queries.
- Knowledge and experience in EDC, key technologies (e.g., IXRS) and industry standards including regulatory regulations, ICH-GCP guidelines, and CDISC-conformant clinical data standards with understanding of SAS, SQL and/or other clinical programming applications.
- Hands-on Medidata RAVE experience essential. Strong understanding of medical data coding classification systems, e.g., MedDRA, WHO-Drug Proficiency with MS Word, Outlook, and PowerPoint experience in core DM activities (e.g., DM Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries). SCDM Certification a plus.
- Strong proficiency in MS Excel including ability to employ functions and generate pivot tables. Strong interpersonal, organizational, and communication (oral and written) skills
- Ability to work effectively in both a team setting and independently with high accountability
- Logical thinking, attention to detail and accuracy, good organizational skills, and problem-solving abilities
- Ability to prioritize and to adapt quickly to changing business conditions with a positive attitude
- Willing to travel if required
- Ability to prioritize workload and meet deadlines, demonstrate effective use of time, and handle multiple assignments simultaneously
- Capable of proactively identifying project challenges and risks and proposing appropriate and strategic solutions to issues
- Preferred: 8+ years in a pharmaceutical/biotech or CRO setting; global/international experience a plus.
- Bachelor's Degree in a scientific discipline (Advanced degree preferred)
Tizona Therapeutics is an Equal Opportunity Employer. We value diversity and are committed to providing employees a workplace free of discrimination and harassment. All employment decisions are based on qualifications, merit and business needs.