Job Description

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CATO SMS and Pharm-Olam, LLC have merged to form Allucent!

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment.

The Data Manager is responsible for effectively participating in the start-up and completion of multiple Data Management projects according to Sponsor and contract requirements and in accordance with applicable standard operating procedures. They may be a study lead for Data Project Manager (DPM) and liaise as appropriate with Sponsor and project team on key issues and progress updates.

This is a full-time, direct hire opportunity for experienced DM Professionals located in Canada and/or Mexico.

YOUR ROLE:

• Effective supervision of all data management aspects of assigned project(s) from setup to lock.
• Attend regular meetings with the Sponsor and project team, for discussions relating to data management issues and provides status updates for the project with guidance from DPM.
• Report on quality and performance metrics, including timelines, to DPM, PM, Sponsor, and, if requested, Management.
• Participate in in-house and external training courses, where required.
• Work in strict adherence to SOPs as well as current ICH-GCP guidelines and other applicable standards required by Regulatory Authorities.
• Participate in the preparation/review of Data Management process control documents, including but not limited to Data Management Plan, Data Quality Checks Specification, User Acceptance Testing, Data Transfer Agreements/Specifications, Reconciliation plans (based on contract), CRF Completion Guidelines, Coding Guidelines, etc.
• Review database validation documentation and approve deployment in conjunction with Data Systems and DPM.
• Coordinate and manage training and EDC access for investigators, coordinators, data entry and CRAs on selected applications for data entry, cleaning, and running reports, as applicable to study parameters.
• Review, freeze and/or lock data in accordance with Data Management documents for accuracy, completeness, consistency and validity, generate queries, as necessary, for sites and/or project team.
• Perform ongoing quality control and data review.
• Participate in eTMF audits performed per contract. Respond to auditors' comments in a timely fashion.
• Participate in the production/coordination of reports and listings for team reviews, Interim Analysis, and/or DSMBs (Data Safety Monitoring Boards), as specified in contract with client.
• Coordinate with Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required.
• Participate in development and finalization of any third-party transfer specifications for electronic database load both to and from Allucent.
• Maintain Data Management study documentation in an 'audit-ready' status, including periodic QC of documentation versioning, approvals and appropriateness.
• Participate in responding to QC comment in a timely manner in conjunction with DPM.
• Perform reconciliation, including but not limited to SAS/AE, Electronic Data Files (EDF) and third-party data such as central labs and IVR, against the clinical database and track issues to resolution.
• Provide DPM with status updates and any issues/risks to deliverables to ensure the project team and Sponsors' are kept informed of all issues and quality performance achieved.
• May present at investigator meetings and PM/CRA training sessions.
• Identifies and recommends process improvements to management team, as identified.

Requirements:

• Preferably a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science or related discipline.
• 5-8 years' experience in clinical data management.
• Previous experience at Data Manager Grade II level (or equivalent).
• Successfully meet study deliverables and exceeds sponsor expectations.
• Manage study resources as a Team Leader, including Data Manager I/II team members.
• Ability to manage multiple mid to large-size global trials from start-up to final end of study deliverables.
• Good communication skills: written and verbal.
• Effective working knowledge of Microsoft Office Suite including Word and Excel.
• Demonstrated problem solving, analytical, organizational and time management skills
• Demonstrated flexibility and ability to work well in a team environment.
• Demonstrates basic understanding of Clinical Trials and the flow of data.
• Demonstrated ability to be compliant with ICH-GCP/regional regulatory guidelines and POI SOPs.
• Comprehension of study documentation standards including Trial Master File organization and archival processes.
• Familiarization of data standards, preferably CDISC STDM.
• Proven knowledge of clinical data management process and clinical database systems, including Electronic Data Capture applications.
• Experience within the CRO industry as a data entry technician or data manager.

Benefits:

We offer a unique working environment with a global team culture, competitive salary and benefits package.

We provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.