Clinical Data Manager

Statistics & Data Corporation (SDC)

3 - 7 years

5 - 9 Lacs

hyderabad

Posted:20 hours ago| Platform:

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Skills Required

project management fda inform medidata rave data validation software testing quality control crf designing edc clinical data management cfr ich gcp clinical research crf writing clinical trials query management data entry communication skills

Work Mode

Work from Office

Job Type

Full Time

Job Description

Independently perform study setup activities including CRF design, database structure design, annotation, DMP, CRF completion guidelines, Data Validation Manual (DVM) creation and/or approval, data entry screen design and testing, validation check testing and approval, etc.
Serve as a primary or backup resource for issues pertaining to data management
Assist other Clinical Data Managers or Project Managers with management of timelines and communication as they pertain to data management activities
Work closely with all levels of Clinical Data Analysts assigned to the studies to ensure completion of study tasks in a timely manner with quality
Assist with data listing review, query management activities at key milestones such as interim analysis, lock, safety reviews etc. as needed
Maintain quality control of the data, project deliverables and closeouts
Support and facilitate the review of medical coding for validity and completeness
Adhere to all aspects of the SDCs quality system
Comply with SDCs data integrity & business ethics requirements
Perform other related duties incidental to the work described herein
Adherence to all essential systems and processes that are required at SOC to maintain compliance to business and regulatory requirements
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills

Competent working knowledge of clinical trials and the clinical data management role in the clinical trials process preferably at a CRO or pharma company
Excellent organizational and project management skills
Able to take lead and work independently to complete all OM activities
Highly effective communication skills, both written and verbal
Technical skills includinq: EDC systems (Medidata Rave and/or iMedNet preferred), , Microsoft Office
Additional required skills include the following: CRF design, MS Project, and analytical capabilities
Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)

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