Clinical Data Manager
Amunix is looking for a Clinical Data Manager (CDM) to own all clinical data management activities for clinical programs to ensure accurate, high quality management of clinical trial data for outsourced trials in a fast-paced environment. She/he will lead the Clinical Data Management function from the ground up and set the strategic direction for the Clinical Data Management function in-house. Experience in oncology is a must, immuno-oncology experience a plus.
- Oversee CRO data managers, including oversight of programming and database build
- Provide expertise in data management to support clinical study plans, including authoring of Data Management study plan documents including Data Management Plans (DMP), Data Transfer Plans (DTP) and Data Review Plans (DRP), and thesaurus coding processes
- Plan, manage and coordinate all global data management activities for assigned program(s) to ensure consistency of clinical data standards across programs
- Critically review protocols and provide feedback as it pertains to data collection and data management activities
- Gather, organize, and analyze clinical data and metadata from multiple data sources
- Lead design of study databases, case report forms (CRFs) and edit checks and Perform User Acceptance Training (UAT)
- Manage and lead the design and implementation of clinical data management processes with vendors
- Ensure completeness, accuracy, consistency and compliance of clinical data and data structure across all assigned programs and drive timely data lock.
- Lead the data review cycle, query management and field ad hoc requests for data listings from other functions
- Review training tools for site and field staff and provide EDC training, as needed
- Represent data management at investigator meetings and potentially present EDC and case report forms to investigators
- Participate in internal study team meetings as well as teleconferences with outside vendors and study personnel
- Support data transfers with CROs
- Enable effective plan for SAE/AE reconciliation
- Experienced with database locking, transfer and archiving of databases
- Bachelor's Degree in a scientific subject area
- Four (4) years as a Clinical Data Manager is REQUIRED
- Minimum of 6+ years in a pharmaceutical/biotech or CRO setting; global/international experience a plus
- Experience supporting PHASE I to III clinical trials is desirable
- Knowledge and experience in EDC, key technologies (eg, IXRS) and industry standards including regulatory regulations, ICH-GCP guidelines, and CDASH/CDISC with understanding of Basic, SAS, SQL and/or other clinical programming applications.
- Strong interpersonal, organizational, and communication (oral and written) skills
- Ability to work effectively in both a team setting and independently with minimal oversight
- 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 deliverables, demonstrate effective use of time and handle multiple assignments simultaneously
- Capable of actively identifying project challenges and risks, and proposing appropriate and strategic solutions to issues.
Amunix is leveraging our expertise in precision protein engineering to enable the promise of T cell engagers in solid tumors. Our goal is to save cancer patients’ lives through the development and commercialization of breakthrough therapies that harness the immune system. We have invented XTEN, a validated therapeutic half-life extension technology. Our current focus is Pro-XTEN, a next-generation protease activated pro-drug platform, which enables selective activation of potent cancer therapies in the tumor microenvironment. This overcomes a common challenge facing potent immune system activators: on-target, off-tumor toxicity. Amunix’s two lead programs employ the Pro-XTEN technology to enhance the safety profile of T cell engagers. XPATs (XTENylated Protease-Activated T Cell Engagers) have the potential to make off-the-shelf therapies redirecting T cells to solid tumors a reality.
Amunix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Amunix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training.
How To Apply
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