Require Clinical Data Manager at MakroCare

MakroCare 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.

Post : Clinical Data Manager

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.

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

Additional Information
Qualification : B.Pharm and above
Experience : 6-10 yrs
Location : Hyderabad, Telangana
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Data
End Date : 24/10/2019