Job Details: Senior Clinical Data Specialist
| Job Title: | Senior Clinical Data Specialist |
| Company: | Makro Technologies Inc |
| Position Type: | Permanent |
| Pay Rate: | 00 |
| Date Posted: | Jun-28-08 |
Job Summary:
Primary Role:
Responsible for organizing and managing clinical data management activities on various clinical projects. The candidate/incumbent should thoroughly understand GCP for Clinical Data Management activities; have experience working with Data Management Contract Research Organizations (CROs) and/or EDC application vendors; have willingness to be involved in start-up of in-house Data Management activities; have understanding of therapeutic indications and study hypothesis.
Must have solid understanding of database design and structure; Medical Coding; and SAE Reconciliation. Familiarity with basic SAS programming is required.
Responsibilities-
Oversee data management activities of Clinical Research Organizations (CROs) and of vendors who provide clinical trial data (eg. imaging vendors, central laboratories, academic laboratories). Participate in the design and development of clinical trials to ensure compliance with GCP/ICH, company SOPs and best working practices. Assist in the development, review and maintenance of data management plans· Participate in User Acceptance Testing (UAT) for EDC studies· Review data discrepancies within clinical database to clean study data· Participate in query management, including generation of queries if required· Review data listings and reports for accuracy and consistency of data· Ensure production and delivery of all Data Management related deliverables as defined in the SOPs· Approve and provision final study deliverables. Ensures all required documentation is completed and appropriately archived· Being a participant on clinical study teams. Acting as the key contact for Data Management related issues or problems, as well as presenting Data Management issues and concerns· Contributes to the tracking of metrics and performance measures both internally and externally· Provide data management-related training to site personnel, CRAs, and Investigators at Investigator Meetings as needed. Responsible for developing, implementing and evaluating clinical data management standards and processes· Performs functional process assessments of CROs, EDC applications, new technologies and 3rd party data providers· Assist in the review of proposal requests responses and in the selection of data management vendors. May be responsible for supervising Clinical Data Management staff· Provide back up support to other staff members as required.
Education & Experience Requirements
B.S. degree in Scientific or related field is preferred·
5+ years of clinical trial data management experience.
Prior trial responsibility for the entire data management life-cycle·
Basic working knowledge of SAS desirable.
Key Skills and Competencies:
Skills:
Exposure to SAS and ability to navigate in SAS environments· Strong attention to detail and accuracy is a must· Ability to read, analyze and interpret complex technical documents· Ability to present complex issues in oral and written form· Strong knowledge of MS Word, Excel, PowerPoint, Access and Outlook· Must be able to independently present complex information to management, CROs and the medical community· Proven ability to manage and communicate effectively with research vendors including negotiating contracts, reviewing requests for proposals, analyzing scope of work, responding to inquires and complaints· Demonstrated ability to manage multiple projects· Prove ability to independently resolve problems· Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines· Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands· Ability to work independently, take initiative and complete tasks to deadlines.
Other Job Components:
Complexity and Problem Solving:
Will make decisions regarding: Best practices for study procedure, set-up, design and management
Day-to-Day Data Management of project activities (scheduling/timelines/conduction of meetings)
Resolution of all data discrepancies- via appropriate contact
Internal and External Contacts
Internal team- Medical Monitor; PVG; Clinical Team; Biometrics Team, Regulatory, Medical Affairs, Bio-analytics External- Data management Vendor; System vendor; Misc Data Vendors.
Other Requirements
1-2 trips a year - domestic or international
| Location: [rss] | US-MA-Lexington |
| Telecommute: | No (Onsite Position) |
| Contact Name: | hima |
| Contact Phone: | |
| Contact Email: | hima.hari@makrotech.com |
Principals only. Recruiters, please do not contact this job poster.
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