Job for Consultant- Clinical Data Management in CDSA - M.Pharm/M.Sc

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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)

Skills:

  • 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.

Experience:

  • 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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