157 Clinicalsafety jobs in India
Senior Aviation Safety Management Systems Specialist
Posted 18 days ago
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Clinical Trials Specialist
Posted today
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We are seeking a highly skilled Central Monitor to play a key role in ensuring the quality and integrity of clinical trial data.
- Critical Responsibilities:
- Study Risk Assessment : Identify potential issues and develop mitigation strategies for clinical studies, collaborating with functional team leads and project managers.
- Statistical Monitoring : Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
- Risk-Based Quality Management Meetings : Support monthly RBQM meetings by reviewing study data, documenting findings, action plans, and coordinating data cleaning activities to support study deliverables.
- Data Quality Assurance : Maintain the highest standards of data quality and integrity through proactive monitoring and timely interventions.
- Collaboration and Communication : Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.
- Reporting and Insights : Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams, driving operational insights and efficiency improvements.
A Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or equivalent combination of education, training, and experience is required. Minimum 2 years experience in clinical monitoring, clinical trial management, or equivalent is preferred. A working knowledge of ICH GCP guidelines and the clinical development process is essential.
Benefits and Requirements- CRO Experience : Preferred qualification as a Central Monitor in a Contract Research Organization.
- Statistical Analysis and Data Monitoring : Experience with statistical analysis and data monitoring techniques.
- Risk Assessment and Mitigation : Ability to assess and mitigate risks effectively.
- Report Writing and Presentation : Strong report writing and presentation skills.
- Collaboration and Teamwork : Excellent collaboration and teamwork skills.
Remote Aviation Safety Management System (SMS) Specialist
Posted 4 days ago
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Key Responsibilities:
- Develop, implement, and manage the organization's Safety Management System (SMS) in accordance with ICAO Annex 19, relevant national aviation regulations, and industry best practices.
- Establish and maintain safety reporting systems, encouraging a non-punitive reporting culture among all personnel.
- Analyze safety data, incident reports, and audit findings to identify hazards and assess risks.
- Develop and implement effective risk mitigation strategies and corrective actions.
- Conduct regular safety audits and inspections to ensure compliance with SMS requirements.
- Facilitate safety action groups and risk management committees.
- Develop and deliver safety training programs to all levels of the organization.
- Promote a positive safety culture through effective communication, awareness campaigns, and leadership engagement.
- Maintain accurate safety records, documentation, and performance metrics.
- Liaise with regulatory authorities regarding safety matters and SMS compliance.
- Stay current with evolving aviation safety regulations, trends, and technologies.
- Provide expert advice on safety-related issues to management and operational departments.
- Contribute to the continuous improvement of the SMS through proactive identification of potential safety concerns.
Qualifications:
- Bachelor's degree in Aviation Management, Aerospace Engineering, Safety Science, or a related field.
- Minimum of 5 years of experience in aviation safety, with a strong focus on Safety Management Systems (SMS).
- In-depth knowledge of ICAO Annex 19, EASA, FAA, or equivalent aviation safety regulations.
- Proven experience in hazard identification, risk assessment, and mitigation planning.
- Familiarity with safety reporting systems and data analysis techniques.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills, with the ability to present complex information clearly and concisely.
- Ability to work independently and manage multiple priorities in a remote setting.
- Proficiency in using safety management software and standard office applications.
- Relevant safety certifications (e.g., certified safety professional - CSP, aviation safety professional - ASP) are a strong asset.
- Demonstrated ability to foster a positive safety culture.
Project Manager (Clinical Trials)
Posted 5 days ago
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Project Manager (Clinical Studies)
**Business Unit:**
Clinical Research
**Location:**
Mumbai
At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Key responsibilities:**
+ Lead a team of clinical research professionals and collaborate with cross-functional stakeholders.
+ Develop and implement project plans, including timelines, milestones, and resource allocation.
+ Define project objectives, deliverables, and success criteria in collaboration with stakeholders.
+ Identify risks and develop mitigation strategies to ensure project success.
+ Allocate resources, assign tasks, and monitor team performance to ensure project goals are met.
+ Develop project budgets, track expenses, and ensure cost-effective utilization of resources.
+ Collaborate with finance and procurement teams to manage contracts, vendor selection, and outsourcing activities.
+ Monitor project progress and resource allocation to ensure efficient utilization and adherence to budgetary guidelines.
+ Ensure adherence to applicable regulatory guidelines, Good Clinical Practice (GCP), and other relevant standards.
+ Oversee the preparation and submission of regulatory documents to ethics committees and regulatory authorities.
+ Implement quality control measures to ensure data integrity, accuracy, and compliance throughout the project
**Job Requirements**
**Educational Qualification**
Bachelor's or Master's degree in a field related to Science, Healthcare, Clinical Research or Life Sciences like Biology, Pharmacology, Nursing, or a related discipline, and/or Post-graduate Diploma in Clinical Research.
**Experience**
Relevant experience of 5-10 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
+ Team Management and creating high performing teams
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Clinical Trials Disclosure Mgr
Posted 5 days ago
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Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Lead the preparation of clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with applicable regulations, guidance, and company requirements
+ Work closely with the transparency and disclosure team and with cross functional stakeholders to define redaction strategy, to ensure timely and accurate registration and results review/approval process, including the redaction process, for US and EU registries, lead cross functional review and approval, ensure submission readiness, and hand off for timely submission or posting
+ Support trend analysis and continuous improvement initiatives
+ Manage projects, coordinate the work of other staff, and prioritize work in order to meet internal and external deadlines
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Working experience with redaction/anonymization of clinical trial documents e.g. for EU CTR, HC-PRCI
+ Working experience with disclosures on public registries e.g. ClinicalTrials.gov
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Good communication skills including excellent spoken and written English
+ Ability to follow controlled processes
+ Leadership skills, including ability to teach, negotiate and influence
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
**Basic Qualifications:**
+ Graduate degree and 2 years of relevant work experience in the pharmaceutical industry
OR
+ Bachelor's degree, and 4 years relevant work experience in the pharmaceutical industry
+ Minimum of 2 years experience in preparation of regulatory documents for public disclosure
+ Familiarity with international regulations, guidance and best practices on clinical transparency & disclosure, including protection of personal information and commercially confidential information
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Clinical Trials Data Scientist
Posted today
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Deliver cutting-edge statistical programming solutions that drive clinical development.
Job Overview:
You will leverage advanced SAS skills and proficiency in CDISC standards to support or lead Phase I-IV clinical trials. Our team fosters a culture of scientific rigor, intellectual curiosity, and collaboration.
Responsibilities:
- Develop and implement data manipulation, analysis, and reporting strategies using SAS programming.
- Generate and validate SDTM and ADaM datasets.
- Design and execute production and QC/validation programming.
- Create complex ad-hoc reports utilizing raw data.
- Evaluate efficacy and prepare submission documents.
- Communicate with internal teams and clients.
Requirements:
- Bachelor's degree in statistics, computer science, mathematics, etc.
- At least 5 years of SAS programming experience with clinical trial data in the pharmaceutical industry.
- Study lead experience, preferably handling multiple projects simultaneously.
- Strong SAS data manipulation and analysis skills.
- Experience with CDISC SDTM/ADaM standards and submissions.
- Excellent analytical and troubleshooting skills.
We offer:
A comprehensive total reward package and world-class employee benefits. We are committed to accelerating drug and device development that saves lives.
Statistical Programmer - Clinical Trials
Posted today
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Unlock your career as a Senior Statistical Programmer.
About the RoleWe are seeking an experienced Senior Statistical Programmer to support our clients in the pharmaceutical industry. As a key member of our team, you will be responsible for designing, developing, and implementing statistical programming solutions to meet the needs of our clients.
The ideal candidate will have a strong background in SAS programming, CDISC standards (SDTM & ADaM), and clinical trial data analysis. You will work closely with cross-functional teams to deliver high-quality results on time.
Key Responsibilities- Data manipulation, analysis, and reporting of clinical trial data using SAS programming
- Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
- Production and QC/validation programming
- Generating complex ad-hoc reports utilizing raw data
- Applying strong understanding/experience of Efficacy analysis
- Creating and reviewing submission documents and eCRTs
- Bachelor's degree in Statistics, Computer Science, Mathematics, or related field
- At least 8 years of SAS programming experience working with clinical trial data in the pharmaceutical industry
- Study lead experience, preferably juggling multiple projects simultaneously
- Strong SAS data manipulation, analysis, and reporting skills
- Solid experience implementing CDISC SDTM/ADaM standards
- Strong QC/validation skills
- Good ad-hoc reporting skills
- Proficiency in Efficacy analysis
- Familiarity with drug development life cycle and experience with clinical trials' data
- Opportunity to work with leading-edge technology
- Collaborative and dynamic work environment
- Professional growth and development opportunities
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Clinical Trials Compliance Specialist
Posted today
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Job Title: Clinical Quality Compliance Manager
Clinical Site Auditor to ensure compliance and quality at Clinical Trial sites.
You will conduct site audits, review documentation, and verify adherence to protocols, GCP, GLP and regulatory requirements.
- Conduct regular audits of clinical research sites across phases I–IV to identify compliance gaps.
- Review and assess CRFs, informed consent forms, and regulatory documents to ensure accuracy and completeness.
- Identify non-compliance issues, document findings, and recommend corrective actions to ensure site staff are trained on compliance procedures.
- Support site staff with compliance guidance and training to enhance their knowledge and skills.
- Prepare thorough audit reports and implement follow-up measures to ensure CAPA implementation and close-out.
Data Analyst - Clinical Trials
Posted today
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Job Description
As a senior statistical programmer, you will be embedded within global pharmaceutical clients to support or lead Phase I-IV clinical trials.
This role can be performed fully remotely. We apply scientific rigor, collaboration, and innovation to create intelligent solutions using leading-edge technology.
- Perform data manipulation, analysis, and reporting of clinical trial data utilizing advanced programming skills
- Generate and validate SDTM and ADaM datasets/analysis files and tables, listings, and figures (TLFs)
- Production and QC/validation programming
- Generate complex ad-hoc reports utilizing raw data
Required qualifications include a bachelor's degree in Statistics, Computer Science, Mathematics, etc., and at least 8 years of SAS programming experience working with clinical trial data in the Pharmaceutical & Biotech industry.
Candidates should have study lead experience, strong data manipulation, analysis, and reporting skills, solid experience implementing CDISC SDTM / ADaM standards, and proficiency in Efficacy analysis.
Key Skills and Qualifications:
Key Skills:
- Advanced SAS programming skills
- Proficiency in CDISC standards
- Study lead experience
Qualifications:
- Bachelor's degree in Statistics, Computer Science, Mathematics, etc.
- At least 8 years of SAS programming experience
Clinical Trials Data Analyst
Posted today
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Job Description
Clinical Trials Data Analyst
We are seeking a skilled Clinical Trials Data Analyst to join our team. As a key member of our global organization, you will be responsible for analyzing and reporting clinical trial data using advanced SAS programming skills.
Your primary focus will be on leveraging your expertise in CDISC standards (SDTM & ADaM) to support or lead Phase I-IV clinical trials. This role offers the opportunity to work fully remotely, allowing for flexibility and work-life balance.
Key responsibilities include:
- Data manipulation, analysis, and reporting of clinical trial data using SAS programming.
- Generating and validating SDTM and ADaM datasets/analysis files and tables, listings, and figures.
- Production and QC/validation programming.
- Generating complex ad-hoc reports using raw data.
- Applying strong understanding/experience of Efficacy analysis.
- Creating and reviewing submission documents and eCRTs.
- Communicating with internal cross-functional teams and clients for project specifications, status, issues, or inquiries.
- Leading duties when called upon.
- Being a team player with a willingness to go the extra distance.
- Being adaptable and flexible when priorities change.
We offer a comprehensive total reward package, world-class employee benefits, supportive policies, and wellbeing initiatives tailored to support you and your family throughout your career.
Our values drive our approach to drug and device development, prioritizing scientific rigor, intellectual curiosity, collaboration, innovation, and effective communication.
In this role, you will have the opportunity to develop your skills and expertise while contributing to the success of our global organization.
Requirements include:
- Bachelor's degree in Statistics, Computer Science, Mathematics, etc.
- At least 5 years of SAS programming experience working with clinical trial data in the Pharmaceutical & Biotech industry.
- Study lead experience, preferably juggling multiple projects simultaneously.
- Strong SAS data manipulation, analysis, and reporting skills.
- Solid experience implementing CDISC SDTM/ADaM standards.
- Strong QC/validation skills.
- Good ad-hoc reporting skills.
- Proficiency in Efficacy analysis.
- Familiarity with drug development life cycle and experience manipulating, analyzing, and reporting clinical trials' data.
- Submissions experience utilizing define.xml and other submission documents.
- Excellent analytical/troubleshooting skills.
- Ability to provide quality output and deliverables under challenging timelines.
- Ability to work effectively in a globally dispersed team environment with cross-cultural partners.