Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Clinical Research Manager
Job Description
1. Act as the project leader of the clinical trial (internal and external team) and execute trial in accordance with project strategy
2. Contribute clinical research and operational expertise in the development of clinical trial design;
3. Providing input to clinical development plans regarding timelines and study feasibility
4. Responsible for the efficient and compliant execution of clinical trials (trial timelines, budget, resources, safety, eligibility, enrollment, data consistency)
5. Responsible for the preparation and/or review of clinical program documents like the Clinical Study Protocol, Report, Investigator Brochure, Annual Report, Briefing Books, and, if applicable, publication.
6. Assure the quality of trial performance and trial documentation by implementing standardized working procedures according to SOPs, GCP and regulatory requirements and by verifying the continual compliance of each trial team member with these procedures. Resolve deviations to procedures by remedial action and training.
7. Perform monitoring / co-monitoring visits according to SOPs
8. Prepare clinical trial medication forecast
9. Planning and tracking of trial budget in line with company financial reporting
10. Proactive knowledge sharing within department, SDC and Sandoz
11. Contribute to preparation of relevant parts of registration documents and interactions with health authorities in context of clinical studies (e.g. scientific advices, deficiencies letters)
12. Active participation in project teams, and contributions to formulation development 13. Contribute to global clinical development activities (e.g. process harmonization, knowledge sharing, participation in working groups)
14. Contribute as agreed with line manager to other clinical related tasks like clinical due diligenc
1. Act as the project leader of the clinical trial (internal and external team) and execute trial in accordance with project strategy
2. Contribute clinical research and operational expertise in the development of clinical trial design;
3. Providing input to clinical development plans regarding timelines and study feasibility
4. Responsible for the efficient and compliant execution of clinical trials (trial timelines, budget, resources, safety, eligibility, enrollment, data consistency)
5. Responsible for the preparation and/or review of clinical program documents like the Clinical Study Protocol, Report, Investigator Brochure, Annual Report, Briefing Books, and, if applicable, publication.
6. Assure the quality of trial performance and trial documentation by implementing standardized working procedures according to SOPs, GCP and regulatory requirements and by verifying the continual compliance of each trial team member with these procedures. Resolve deviations to procedures by remedial action and training.
7. Perform monitoring / co-monitoring visits according to SOPs
8. Prepare clinical trial medication forecast
9. Planning and tracking of trial budget in line with company financial reporting
10. Proactive knowledge sharing within department, SDC and Sandoz
11. Contribute to preparation of relevant parts of registration documents and interactions with health authorities in context of clinical studies (e.g. scientific advices, deficiencies letters)
12. Active participation in project teams, and contributions to formulation development 13. Contribute to global clinical development activities (e.g. process harmonization, knowledge sharing, participation in working groups)
14. Contribute as agreed with line manager to other clinical related tasks like clinical due diligenc
Candidate Profile
MSc or PhD in Life Sciences Fluent in English (oral and written)
1. Minimum 5 years experience in clinical development or associated fields
2. Knowledge of pharmacy, pharmacokinetics, bioanalysis, statistics and/or clinical trials 3. Solid knowledge of GCP and worldwide regulatory requirements related to assigned area
4. Solid medical/scientific writing skills
5. Computer literacy
6. Ability to analyze, discuss, interpret and present scientific data
7. Strong communication and organizational skills
8. Proven people management skills with demonstrated expertise in working on teams
9. Flexible to travel
MSc or PhD in Life Sciences Fluent in English (oral and written)
1. Minimum 5 years experience in clinical development or associated fields
2. Knowledge of pharmacy, pharmacokinetics, bioanalysis, statistics and/or clinical trials 3. Solid knowledge of GCP and worldwide regulatory requirements related to assigned area
4. Solid medical/scientific writing skills
5. Computer literacy
6. Ability to analyze, discuss, interpret and present scientific data
7. Strong communication and organizational skills
8. Proven people management skills with demonstrated expertise in working on teams
9. Flexible to travel
Additional Information
Experience : 5 years
Qualification : M.Sc or Ph.D
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 30th April, 2018
Experience : 5 years
Qualification : M.Sc or Ph.D
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 30th April, 2018
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