Principal Clinical Data Trial Manager (Remote)

Description:

• Provides Data Management leadership for one or more assigned programs or indications. Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i:e ensuring consistency across data quality plans
• Leads and coordinates the data management activities of internal teams and vendors including the design and implementation of clinical databases and other data collection systems as applicable.
• Manage data activities for all assigned clinical trials: such as review of CRFs, writing CCGs and edit checks specs, and DMP, conducting UATs, reviewing clinical data, writing/review/closing queries, reconciling external data, and locking the clinical database
• Assists with development of templates (e.g. trackers and/or listings) for identifying and reporting clinical study metrics: including visit/page status, query metrics and data gaps, outliers and trends.
• Responsible for projects that have been contracted with contract research organizations. Manages vendor staff for assigned projects, ensuring proper quality oversight and delivery within budget.
• Maintains awareness of the status of start up, conduct and finalization activities for all trials within assigned program(s) Tracks and requests necessary resources.
• Support the development of data management infrastructure including standard operating procedures, working practice documents, vendor oversight standards, and report templates.
• Manages medical coding and AE/SAE reconciliation activities and on assigned studies
• Supports other functional areas such as statistical programming, biostatistics and medical writing when appropriate.
• Is able to provide solutions to effectively meet timelines
• Develops risk management strategies to prevent data quality issues from derailing projects
• Represents Data Management at cross functional forums, meetings and provides timely feedback to partners.
• Review protocol, TLFs, SAP and all data science documents
• Ensure study TMF is inspection ready for assigned studies
• Ensures data management activities are conducted in accordance with GCP, GCMP, internal SOPs and all regulatory requirements.
• Participates in RFP development, contract negotiation and selection of DM and/or technology, as needed.
• Prepare and provides training of the CRF completion guidelines, EDC system at Investigators' meeting and to internal and external project members as needed.
• Manages the database design process. Participates in EDC User Acceptance Testing (UAT) or QC.
• Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner. Oversee and review the data transfer specification for the EDC and other third-party data.
• Performs DM activities for start-up and close-out of clinical studies.
• Responsible for the supervision and growth of individuals within the data management department.

Additional Skills & Qualifications:

• At least 5 years of experience of being a Clinical Trial Data Manager at a pharmaceutical company (Sponsor)
• Oncology clinical research experience required. Having experience in early Phase I/II Dose Escalation and Dose Expansion clinical research trial is helpful.
• Have knowledge of GCP, and basic understanding of clinical trial design, regulatory processes, and clinical drug development process. Understands Health Authority requirements and is able to prepare for and participate in Health Authority inspections and audits as required
• Strong Knowledge of SDTM and ADaM datasets.
• Experience with data programming tools and/or data viewing tools (J-Review, SAS, etc.)
• Have knowledge of GCP, and basic understanding of clinical trial design, regulatory processes, and clinical drug development process.

Experience Level:

Expert Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Salary : $70 - $80