Key Accountabilities
- Assume the ability to meet the requirements of a CDA I and II with a high degree of proficiency and autonomy
- Act as an independent CDM Coordinator on complex or multiple projects, CMA/CDA Coordinator on smaller 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 GRO Lead
- Represent function in external client meetings and presentations such as investigator meetings and bid defenses as required.
- 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, PMED, IVRS, MS-Office products such as Excel, Word.
- Sound awareness of all relevant regulations, including GCP
- Posses 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
- Ability to make appropriate decisions in ambiguous situations
- Ability to solve problems by using a logical, systematic, sequential approach • Communicate and work effectively with clients
- Enlists the support of team members in meetings goals
- Proposes new approaches, methods or technologies
- Anticipates how others will react to situations
- Effective time management in order to meet daily metrics or team objectives
- Shows commitment to and performs consistently high quality work
- Plans and delivers verbal and written communications that persuade the intended audience
- Willing and able to travel as required – local or international Education
Qualifications
- Bachelor’s degree and / or other medical qualification or relevant DM experience
Language Skills • Excellent in written and oral English
Minimum Work Experience • Previous relevant working experience preferred, or data management, clinical and / or research experience with solid understanding of clinical trials methodology and terminology