Clinical Trial Head | Wockhardt – Regenerative | Mumbai

Job Description

Roles and Responsibilities:

• 1. General Initiate and complete CTs in therapeutic areas

  a) Design and develop of clinical protocols for various medical conditions

  b) Design and develop experimental therapy strategies for various medical conditions in collaboration with Hospital clinicians.

  c) Design and develop local and global strategies for the launch of standard therapy with clinical trials as per regulatory approvals/obtain marketing license

  d) Initiate pilot studies as per approved protocols in stem cell therapy and collate data for publications in peer review and leading clinical journals.

  e) Ensure funding for clinical research from external endowments and scientific bodies as part of collaborative research

  f) Work closely with scientific team and clinicians in the design of novel therapies for stem cell clinical application

  g) Develop a team of technical experts through on the job training and course enrollment

  2. Administrative Documentation of IC-SCRT/ IEC/ Clinical trials at various locations

  3. Personnel Duties Develop second line, interact between trial sites and laboratory

  4. Medical/Staff – train medical staff for CRFs etc

  5. Public Relations Interact with Prinicipal Investigators, Management representative on the IC-SCRT

Desired Skills Set:

• Enthusiasm Verbal Ability/Communication Skill – High
• Technical Knowledge of ICH-GCP compliant, DCGI approval process, ICMR guidelines on stem cell research and therapy
• Analytical Skill – High
• Interpersonal Skill – High
• Problem Solving/Decision Making – High

Others:

• Empathy
• Punctuality
• Leadership qualities

Qualification: MBBS, Medical-MS/MD in Pharmacology, Ph.D/Doctorate in Biotechnology

Desired Skills: ICMR, Clinical Research, Clinical Trials, Clinical Development, GCP-ICH Guidelines, DCGI, Stem Cells, Pharmacologists