Clinical Data Manager, Senior in Oro Valley, AZ at Apex Life Sciences

Date Posted: 3/5/2018

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Job Description

Large, International Medical Device Company looking for a Senior Clinical Data Manager for a 12 month contract that could convert to a permanent position.  A team of experienced professionals will guide you through our projects amid a beautiful facility with many amenities and mountains views.  This position will start ASAP and work Monday – Friday during the day. Home based work is possible for a strong candidate.


The Senior Clinical Data Manager performs data management activities for both clinical and development projects. Ensures the delivery of complete, accurate data that is ready for analysis and regulatory submission; defines and applies study-specific data management workflow; interacts with internal and external teams to define study-specific data requirements; participates in database planning and user acceptance testing of database; and organizes and facilitates data entry and data management tasks to ensure timely, high-quality study deliverables. Has primary ownership of one or more projects. Participates in department and/or company continuous improvement initiatives.


-        Functions as Lead Data Manager for assigned projects, acting as the primary point of contact for clinical data management issues for the study team.

-        Uses knowledge of clinical data management to define data flow for assigned projects. Identifies and implements updates to study-specific processes as needed.

-        Creates or oversees creation of data management documentation for assigned projects, including the Case Report Form (CRF), Data Management Plan (DMP), and clinical database specifications. Maintains robust documentation to ensure and/or document regulatory compliance at all times. Identifies and implements updates to documentation as needed.

-        Uses knowledge of database management to define clinical database requirements. Performs user acceptance testing of clinical database and edit checks.

-        Provides study-specific data entry training to data entry staff. Oversees data entry staff to ensure data quality.

-        Performs clinical study data review as required by the DMP. Identifies incomplete, erroneous, and/or discrepant data and uses discretion to resolve issues. Identifies and manages data trends.

-        Manages data discrepancy process to ensure discrepancies are generated and resolved in a satisfactory and timely manner as part of the study team. Uses professional judgment to escalate issues appropriately.

-        Updates clinical database based on queries, data clarification forms, discrepancy management guidelines, and performs other database changes as necessary for a study.

-        Maintains proficiency in use and analysis of clinical database system(s) and overall awareness of clinical data management practices by reading related literature, attending training classes and professional meetings, and participating in project-specific training sessions.

-        Assigns project-specific tasks to junior data management staff.

-        Performs other duties as assigned.

Knowledge, Skills, and Abilities:

-        Familiarity with regulatory and ICH-GCP guidelines as applicable to data management. 

-        Ability to work with relevant computer software packages, including spreadsheets and word-processing packages (e.g., Microsoft Excel, Microsoft Word), is essential.

-        Ability to work with relational database software (e.g., Medrio, Microsoft Access, Oracle Clinical, RAVE, Inform, etc.) is essential. 

-        Excellent communication and interpersonal skills.

-        Ability to collaborate across departments and interact with various levels in the organization.

-        Ability to work under time pressure while maintaining high standards of precision and data quality.

Formal Training/Education:

-        A minimum of a Bachelor’s Degree is required.

-        A Master’s degree is helpful.


-        Minimum 3 years of experience in data management or related fields.

Senior Clinical Data Manager Skills Needed / Manager’s Must Haves:

-MUST have lead data management experience, not a 'task lead' but overall project lead, e.g. sponsor-facing if coming from a CRO background.

?-The Sr. CDM is expected to be a fully-independent lead data manager, capable of drawing on their experiences in new situations.

-MUST have solid communication skills, both verbal and written.

-The Sr. CDM must be a self-starter, intellectually curious in seeking out answers and driving projects proactively.

-Preference will be given for candidates with a solid work history, rather than multiple short stints at numerous places

-CCDM preferred, but not required.

?-Home-based candidates must be highly skilled, exceptional communicators with a long track record of consistent experience and an established home-based office including reliable internet connection. Travel to AZ each quarter will be anticipated if working home-based

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