Job Description
Responsibility for ensuring high quality clinical trial data review/insights and analysis as directed by the Integrated Clinical Trial Team (iCTT):
1. Perform high quality clinical data review and identify clinical data insights through patient level review and trends analysis, supporting Interim Analysis, Database and Post Lock activities and facilitate resolution of clinical data issues. Collaborate with relevant line functions to enhance the quality of clinical data review/insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
2. Contributes to the development the Data Review/Quality Plan (DRP/DQP) and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study.
3. In conjunction with the relevant line functions, may contribute to Case Report Form (CRF) development, and support the implementation of data capture tools.
4. Contribute to and facilitate data review process improvements e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools.
5. May contribute (in collaboration with relevant line functions) to the development of study-level documents, including clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. In collaboration with relevant line functions, review/write clinical trial documents for study CSR activities, and publications.
6. May support pharmacovigilance activities (e.g., reviewing/contributing to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)), if required. 7. Produce training materials and provide training to iCTT.
8. Support/present at study level meetings (Investigator Meetings, Data Monitoring Committee (DMC) meetings or others), as required.
Responsibility for ensuring high quality clinical trial data review/insights and analysis as directed by the Integrated Clinical Trial Team (iCTT):
1. Perform high quality clinical data review and identify clinical data insights through patient level review and trends analysis, supporting Interim Analysis, Database and Post Lock activities and facilitate resolution of clinical data issues. Collaborate with relevant line functions to enhance the quality of clinical data review/insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
2. Contributes to the development the Data Review/Quality Plan (DRP/DQP) and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study.
3. In conjunction with the relevant line functions, may contribute to Case Report Form (CRF) development, and support the implementation of data capture tools.
4. Contribute to and facilitate data review process improvements e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools.
5. May contribute (in collaboration with relevant line functions) to the development of study-level documents, including clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. In collaboration with relevant line functions, review/write clinical trial documents for study CSR activities, and publications.
6. May support pharmacovigilance activities (e.g., reviewing/contributing to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)), if required. 7. Produce training materials and provide training to iCTT.
8. Support/present at study level meetings (Investigator Meetings, Data Monitoring Committee (DMC) meetings or others), as required.
Other responsibilities include:
1. Develop subject matter expertise (disease area knowledge, clinical data review tools and/or processes).
2. Contribute to Clinical Development and Analytics (CD&A) line function initiatives, local and/or global education and process development projects, as required.
1. Develop subject matter expertise (disease area knowledge, clinical data review tools and/or processes).
2. Contribute to Clinical Development and Analytics (CD&A) line function initiatives, local and/or global education and process development projects, as required.
Candidate Profile
Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master’s, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred. Fluent English (oral and written) 1-2 years scientific, strategic and operational experience in planning, executing, reporting and publishing clinical studies in industry or Academia, or 3-4 years in Clinical Operations/Clinical Scientific role Intermediate knowledge of planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization or similar experience with an academic research institution Good knowledge of Good Clinical Practice and drug development processes Strong scientific knowledge in at least one therapeutic area (e.g., understanding of basic mechanisms of diseases and associated symptoms, standard of care/treatment, scientific endpoints & clinical outcomes) Knowledge of principles of clinical data collection and reporting; ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting. Experience in Rave and/or OC-RDC is an advantage.
Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master’s, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred. Fluent English (oral and written) 1-2 years scientific, strategic and operational experience in planning, executing, reporting and publishing clinical studies in industry or Academia, or 3-4 years in Clinical Operations/Clinical Scientific role Intermediate knowledge of planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization or similar experience with an academic research institution Good knowledge of Good Clinical Practice and drug development processes Strong scientific knowledge in at least one therapeutic area (e.g., understanding of basic mechanisms of diseases and associated symptoms, standard of care/treatment, scientific endpoints & clinical outcomes) Knowledge of principles of clinical data collection and reporting; ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting. Experience in Rave and/or OC-RDC is an advantage.
Additional Information
Experience : 1-4 years
Qualification : Pharm.D, M.Pharm, Ph.D, MBBS, BDS, MD
Location : Hyderabad, AP
Industry Type : Pharma
Functional Area : R&D
End Date : 20th March, 2019
Experience : 1-4 years
Qualification : Pharm.D, M.Pharm, Ph.D, MBBS, BDS, MD
Location : Hyderabad, AP
Industry Type : Pharma
Functional Area : R&D
End Date : 20th March, 2019
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