This is an excellent opportunity to work with leading clients in the lifescience industry.

Makrocare provides outstanding Clinical Data Managementservices for local and international studies. We handle all phases of clinical research across the full spectrum of therapeutic areas.

Our services covers activities ranging from case report form and database design to database lock and report submission.

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
• 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 
• 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

Job Requirement:

• 6-10 yrs of experience in Clinical Data Management
• 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
• 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