Job for Consultant- Clinical Data Management in CDSA - M.Pharm/M.Sc
Clinical Development Services Agency (CDSA) has therefore been formed as a not-for-profit society to provide supportive and focused environment to host world class clinical translation through a collaborative network of clinical investigators and premier research institutions. It will tend enterprises, particularly SMEs involved in new technology innovation, to facilitate translation of scientific know-how into viable products for public health diseases like malaria, tuberculosis and dengue among others.
Post: Consultant- Clinical Data Management
Emoluments: (up to Rs. 75,000/- per month consolidated)
Qualification: Master’s degree level (biological/ life science, pharmacy or other health related discipline preferred)
Good oral and written communication skills in English.
- Demonstrated ability to work independently and in a multidisciplinary team.
- Demonstrated ability to manage and motivate direct reports.
- Excellent interpersonal, verbal and written communication skills, (including experience in making presentations at conferences, meetings, training sessions)
- Able to role model behaviours and ethics in line with CDSA Mission, Vision and Values.
- IT literate.
- Knowledge of SOPs/ Guidelines/ System Life Cycle methodologies, GCP and any other.
- Applicable local regulations and proven practical application.
- Tenacity to work in an innovative environment.
- Personal skills include ability to manage competing priorities, function independently, attention to detail, excellent organizational skills, and flexibility to change and fulfilling activities to completion.
- Demonstrated ability to learn new systems and function in an evolving technical environment.
8-15 years in clinical data management with at least 5 years of management experience.
Sound understanding of the global drug development process.
Ability to develop/advise on training programs for Data Scientists/Technicians and data management workshops for Clinical Research staff.
Ability to establish strong working relationships with others in the drug development process, particularly within Clinical Research.
Familiarity with SAS programming.
Well-versed in regulatory requirements for validation of data management systems, GxP, Good Clinical Data Management Practices (GCDMP).
Experience in various phases of clinical trials with full project life cycle experience (CRF design to database lock and reporting); use of commercial and/ or proprietary clinical data management systems, coding dictionaries/encoding systems (e.g. MedDRA, WHODRL), other software in support of data management activities (e.g SAS, Access, SQL, Oracle), programming skills and experience with electronic data capture a definite plus
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