Clinical Data Manager

Nexcella, Inc.; Montreal (administrative region); On-site; CAD 65,000 - 95,000; Full time

Job summary

Nexcella, Inc. in Montreal seeks a Clinical Data Manager to design eCRFs, review and validate clinical databases, and ensure data integrity across trials.

You will create data management plans and documentation with minimal oversight, support moderate to complex studies, monitor data QC, and coordinate with Medical Affairs and Clinical Operations to keep projects on target and compliant with GCP standards.

Qualifications

• 2+ years of clinical data management experience in Medical Device or Pharmaceuticals.
• Knowledge of regulatory requirements for clinical data management documentation.
• Experience with EDC and data validation processes.

Responsibilities

• Design eCRF and validate clinical database.
• Create data management plans and docs with minimal oversight.
• Support moderate to complex trials with minimal supervision.
• Monitor progress, data cleaning and QC to meet timelines.
• Coordinate data management activities from initiation to database lock.
• Participate in ongoing data review and corrections throughout the study.
• Identify issues impacting data quality, deliverables or timelines.
• Handle non-CRF data including lab data and image handling.
• Coordinate with Medical Affairs for data coding and safety reviews.
• Ensure all data management documentation is archived timely and compliant.
• Follow regulations with professionalism and ethics.
• Perform other related duties as required.

Skills

Oncology knowledge

Communication

GCP compliance

EDC experience

Coding dictionaries

Education

Biological sciences degree

CS or related discipline

Job description

• Design eCRF (electronic case report form), review and validation of clinical database.


• Be responsible for creation of data management plans and other data management documentation as needed with minimal oversight.


• Support a number of moderate complexity / complex trials with minimal supervision.


• Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines.


• Be responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock with minimal oversight, partnering as appropriate with Clinical Operations, Franchise and other functions for their respective projects.


• Be responsible for participating in ongoing data review throughout the conduct of the study, including being responsible for the correction of errors and discrepancies management for the life of a project.


• Proactively identify and address issues that may impact the quality of the data, deliverables or timelines.


• Be responsible for handling of non-CRF data, including lab data and image handling.


• Be responsible for coordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed.


• Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner.


• Know and follow all regulations that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times.


• Performs other related duties as required.

What We Look For

• Therapeutic area knowledge in oncology preferred


• Strong verbal and written communication skills.


• Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software.


• Experience with Electronic Data Capture (EDC)


• Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug).


• A degree (or equivalent) in the biological sciences, Computer Science or related discipline, with at least 2 years of clinical data management experience in Medical Device or Pharmaceuticals

Nexcella, Inc. is a subsidiary of Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a proprietary CD3ζ, CD8 hinge and binder "digital filter" designed to filter out non‑specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 is being evaluated in the U.S. multi‑center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a potentially registrational design. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn more at www.nexcella.com and www.BeProactiveInAL.com.