Clinical Data Management

4 days ago

Toronto, Canada Bio Pharma Services Full time

Clinical Data Manager

Position Summary:
The Clinical Data Manager is responsible for the set up and management of the clinical study database, the collection and quality of the clinical study data and the preparation of the clinical data to current regulatory and industry expectations and standards.

Duties and Responsibilities:

- Independently perform all activities related to data management per regulations and applicable standard operating procedures (SOPs)
- Provide guidance to junior members of the Data Management group
- Develop, test and lock study specific databases and clinical study data for mainly Phase I and BA/BE clinical studies and potentially for Phase II-IV clinical studies
- Responsible for reviewing and contributing to protocols from a data management perspective
- Manages the process from DMP development to data entry, data cleaning and data transfer, data lock to data export
- Create Data Management Plans (DMP) and other data management documents for projects as required and manage the execution of all plans
- Design and review eCRFs according to the study protocol, set up database, perform user acceptor testing (UAT) and lock database and study data
- Creates data dictionary for data users
- Manages the medical coding process internally or through external vendors
- Develop, review and execute electronic data edit checks for web-based forms
- Perform Data Entry and Quality Control (QC) on study data and programs as needed
- Create, review, and process data queries and updates the databases
- Query data inconsistencies and revise case report forms in compliance with SOPs, client guidelines and regulatory agency guidelines
- Perform third party non-CRF data management activities, including data transfers and Serious Adverse Event (SAE) Reconciliation
- Works collaboratively with other Pharmacokinetics staff, Biostatisticians, cross-departmentally within BPSI to meet project deliverables and timelines for clinical statistical programming and reporting
- Efficient collaboration with the team from vendors to ensure timely deliverables with high quality
- Participates in and may lead process improvement activities within the department and cross functionally, including SOP development
- Coordinate with the immediate supervisor or Manager Data Management to track and report status and progress of data management activities for allocated trials and be proactive to ensure smooth, successful and timely locking of databases
- Serve as trainer/mentor for Data Management associates
- May coordinate with Lead Data Manager/Senior Data Manager to ensure that assigned trials are managed efficiently with high quality
- Other duties & responsibilities as required

Qualifications:

- At least 3 years of experience in Data Management, performing activities in setup, conduct and locking of clinical data
- BA or BS with a science or related background; equivalent experience in data management and a medical-related field may be substituted
- In-depth understanding of database structures and database programming
- In-depth knowledge of CDISC standards, especially CDASH and SDTM
- In-depth knowledge of clinical trial processes and experience in, ICH GCP, and GCDMP (SCDM)
- Strong analytical and problem-solving skills
- Must have strong communication (both verbal and written), interpersonal, and client services skills, be highly organized and self-motivated
- Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail
- Ability to be flexible and adapt to change, to work independently, and take a leading and collaborative role in multi-disciplinary teams

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