Reporting to the VP, Clinical Operations, the Senior Clinical Data Specialist is responsible for supervising data management activities from clinical study initiation through closure, data analysis, and reporting to ensure the data is accurate, complete, and compliant with International Council for Harmonisation (ICH): Guideline for Good Clinical Practice (GCP), applicable regulations and industry standards, as well as 35Pharma Inc. standard operating procedures (SOP)/policies/work instructions.
The Senior Clinical Data Specialist liaises with internal and external stakeholders, including contract research organizations (CROs) and data vendors, ensuring study data integrity and timeliness of key data deliverables. The Senior Clinical Data Specialist will support Clinical Operations in developing solutions that support data-driven decision-making.
Key Responsibilities:
- Accountable for CRO oversight of all outsourced data management activities and deliverables as well as management of internal data activities within Clinical Operations.
- Oversees the development and collaboration with internal teams and vendors on all study-level data management documents.
- Oversees electronic data capture (EDC) and other clinical systems build and participates in user acceptance testing (UAT) for new builds and mid-study updates.
- Supports study team members, including CRO counterparts and sites, on data capture questions and data-related issues.
- Leads internal data analytics and reporting across multiple systems.
- Oversees the coordination and facilitation of internal cross-functional data reviews.
- Reviews data metrics, performs trend analyses, and escalates concerns/risks.
- Collaborates with Clinical Project Managers in vendor management activities (e.g., CRO, laboratory, imaging vendors) related to data quality, integrity, and transfers.
- Provides cross-functional collaboration and communications to increase data quality and timely data milestones.
- Oversees data imports and merges from multiple systems, corrects discrepancies, and ensures quality.
- Collaborates on the development and maintenance of dashboards to provide data analytics.
- Evaluates and establishes data management key performance indicators and develops action/escalation plans accordingly.
- Monitors and improves data collection processes, partners to identify how to standardize data across multiple systems, and provides recommendations for enriched reporting and data standards.
- Collaborates with Clinical Project Managers to monitor budget and scope of work for contracted data management services.
- Collaborates with Clinical Project Managers for the tracking of data management timelines, ensuring that all applicable stakeholders are aware and on target for deliverables, including EDC go-live, mid-study system updates, interim data snapshots, and database locks.
- Identifies and escalates project and quality issues; supports corrective/preventive actions as required.
- Supports study-specific quality audits and regulatory authority inspections.
- Assists in training and mentoring of other Clinical Operations personnel in data management activities.
- May support any clinical and regulatory operations project activities as deemed necessary to ensure the clinical program success.
Qualifications:
- Bachelor’s degree in a related field or degree in computer sciences (e.g., life sciences, data management) or equivalent experience.
- Minimum of 8 years experience in clinical data management in a pharmaceutical or biotechnology company, or a CRO, including 5 years in a lead data manager experience with database design and development.
- Expert understanding of global data operations tasks, specifically within data management and database programming and relevant data standards.
- Demonstrated technical experience with EDC (preferably Medidata) and other clinical systems (i.e., Clinical Trial Management System (CTMS), Randomization and Trial Supply Management (RTSM)).
- Expert understanding of relational databases and data capture standards (e.g., CDASH).
- Strong ability to identify and resolve complex challenges using critical thinking skills.
- Excellent organizational and record-keeping skills with strong attention to detail, precision, and accuracy.
- Good oral and written communication skills (This position involves daily collaboration with suppliers, teams, and partners located outside of Quebec, requiring a strong knowledge of English by the candidate).
- Ability to prioritize, organize, plan, and successfully execute multiple tasks and priorities simultaneously.
- Ability to prepare and present data reports.
- Advanced computer skills, including proficiency in MS Office (Word, Excel, PowerPoint), including with complex pivot tables and data analysis.
- An unwavering commitment to the highest quality of work, research ethics, and willingness to learn.