Clinical Data Manager @ MakroCare, B Pharmacy and above
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.
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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