Job Description

Job Id   2521659
Title   Clinical Data Manager
Category   Clinical
Job Status   Full Time
Job Type   Permanent
No of Openings   1
Salary   
Region   Asia Pacific
Country   India
State   Telangana
City   Hyderabad
Zip   500081
Posted On   1/23/2020
Expires On   4/23/2020
Years of Experience   6 to 10
Contact Person   Rajesh Neelam
Contact Email   talent.hr@makrogrp.com
Contact Number   
Job Description   
    MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.

    www.makrocare.com

    Educational Qualification: B pharmacy and above.

    Years of Experience: 6  to 10 Years

    Top primary skills required for this role:

    Good computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, knowledge of MS-Office products such as Excel, Word.
    Sound awareness of all relevant regulations, including GCP

    Secondary skills required for this role:

    Ability to organize and plan tasks
    Shows commitment to and performs consistently high quality work
    Excellent interpersonal, verbal and written communication skills
    Sense of urgency in completing assigned tasks.

    Tertiary skills required for this role:

    Plans and delivers verbal and written communications that persuade the intended audience.
    Sense of urgency in completing assigned tasks.

    Job Description:

    Assume the ability to meet the requirements of a Manager with a high degree of proficiency and autonomy.

    Act as a study lead on complex or multiple projects.

    Manage all phases of data management activities from study start up to database close - Direct team members in daily activities.

    Define and monitors metrics and modifies plan accordingly - Mentor project team members - If required, facilitate cross functional team meetings both internally and externally.

    Actively review and provide feedback on study productivity - Recognize out of scope activities and communicates to Group Head.

    Reviewing and providing inputs on CRFs (Unique and Expanded), Visit matrix doc and study specific Data Management Plan.

    Reviewing and providing inputs on project specific guidelines, e.g. SAE handling, Medical Coding, Third Party data handling and Universal ruling guide lines documents.

    Overall supervision of Screens UAT procedure and responsible for its documentation.

    Reviewing and providing inputs on Edit Checks document.

    Overall supervision of Edit Checks UAT procedure and responsible for its documentation.

    Reviewing and providing inputs on study specific eCRF filling instructions.

    Reviewing and providing inputs on Data Cleaning, Data Reconciliations and Data Quality. 

    Requires minimal supervision by Manager.
     
    Apply knowledge across multiple projects - Define study specific processes - Identify inconsistencies and inefficiencies in processes and recommends solutions Skills - Excellent interpersonal, verbal and written communication skills.

    Excellent computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, mPortal, IVRS, MS-Office products such as Excel, Word.

    Sound awareness of all relevant regulations, including GCP - Proses a thorough understanding of the various tasks related to project initiation, ongoing monitoring / processing and lock.

    Carefully weighs the priority of project tasks and directs team accordingly - Understands the strengths and development areas of team members.

    Ability to lead a -virtual-, global team as required - Gives others appropriate latitude to make decisions - Looks for win-win solutions to solve problems.
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