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
No of posts : 01
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.
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
Experience : 6 to 10 years
Location : Hyderabad, Telangana
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Clinical
End Date : 23/04/2020
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