Clinical Data Manager
Covance
Mississuaga, Ontario
14d ago

Permanent, salaried

Location : Remote (US or Canada)

JOB SUMMARY

Hands on project data processing tasks. Work to departmental SOPs, guidelines and global standards to ensure data integrity.

JOB RESPONSIBILITIES

Thorough understanding of Clinical Data Management tasks and assigned protocol(s) with ability to critically evaluate the information in relation to other key project documents and processes.

Monitor tasks vs. contractual obligations for CDM and report any out of scope items to the Lead Project Data Manager. Provide oversight to external suppliers such as EDC vendors.

Coordinate, create and maintain the Data Management Plan, eCRF Completion Guidelines and training materials. Work with KickStart and Sponsor on start-

up activities. Sign off on documentation as required by SOPs and WPGs. Attend & present CDM materials at Investigator & CRA meetings.

Attend internal and external project meetings providing input from a CDM perspective. Ensure assigned actions are completed within the required timeframe.

Assist with tracking of project status, task completion, and staff productivity. Determine status of incoming data, site responsiveness, need for escalation for backlog to various functions within Theorem or sponsor.

Report and discuss findings with Lead Project Data Manager.

Review and approve post production change control study documentation.

Ensure filing of study specific documentation as required by SOPs and WPGs and study needs. Maintain all data management study documents in the designated TrialShare area and PMF as required.

Provide reports to Sponsor and internal team as dictated by project need.

Be a resource to CDM team for questions and guidance as related to clinical data.

KEY SKILLS & BEHAVIORS

Exemplify, deliver and expect professionalism using strong interpersonal and organizational skills

Keeps an internal and external client informed of project and / or technical issues by pro-actively communicating across teams / functions

Communicates effectively through both written and verbal methods

Anticipates changing priorities and demands and addresses them proactively

Manages time effectively in order to produce a quality deliverable in expected timeframe

Exemplify, deliver and expect professionalism using strong interpersonal and organizational skills

TRAINING AND EXPERIENCE

Bachelor’s degree in Medical or Life Science, Mathematics or RN

Five plus years experience in CDM in a CRO or the pharmaceutical industry

Occasional Travel

Education / Qualifications

TRAINING AND EXPERIENCE

Bachelor’s degree in Medical or Life Science, Mathematics or RN

Five plus years experience in CDM in a CRO or the pharmaceutical industry

TRAINING AND EXPERIENCE

Bachelor’s degree in Medical or Life Science, Mathematics or RN

Five plus years experience in CDM in a CRO or the pharmaceutical industry

Position Type Full-Time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority / Female / Individual with Disability / Veteran / Sexual Orientation / Gender Identity).

Your confidentiality and privacy are important to us.

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