• Clinical Development Manager Jobs in Hyderabad,India - 25368946

  • Novartis AG
  • Save Job
  • 5 - 8 Years
  • Posted : above 1 month

Job Description:

Job ID 283929BR

Position Title Clinical Development Manager

Your responsibilities
Your responsibilities include, but are not limited to

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 (eg scientific advices, deficiencies letters)
12 Active participation in project teams, and contributions to formulation development
13 Contribute to global clinical development activities (eg process harmonization, knowledge sharing, participation in working groups)
14 Contribute as agreed with line manager to other clinical related tasks like clinical due diligence

Minimum requirements MSc or PhD in Life Sciences Fluent in English (oral and written)
Minimum 5 years experience in clinical development or associated fields
Knowledge of pharmacy, pharmacokinetics, bioanalysis, statistics and/or clinical trials
Solid knowledge of GCP and worldwide regulatory requirements related to assigned area
Solid medical/scientific writing skills
Computer literacy
Ability to analyze, discuss, interpret and present scientific data
Strong communication and organizational skills
Proven people management skills with demonstrated expertise in working on teams
Flexible to travel
Why consider Novartis

750 million Thats how many lives our products touch And while were proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this how can we continue to improve and extend even more peoples lives

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment Where youre given opportunities to explore the power of digital and data Where youre empowered to risk failure by taking smart risks, and where youre surrounded by people who share your determination to tackle the worlds toughest medical challenges

We are Novartis Join us and help us reimagine medicine

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons

Division SANDOZ

Business Unit Product Dev SZ

Location India

Site Hyderabad, AP

Company/Legal Entity Nov Hltcr Shared Services Ind

Functional Area Research & Development

Job Type Full Time

Employment Type Regular

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 09th Jun 2020

Key Skills:

People who search this job also searched for the following Keywords

All rights reserved © 2018 Wisdom IT Services India Pvt. Ltd DMCA.com Protection Status