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📑 JOB DETAILS 1. Prevent the payment of potentially fraudulent and/or abusive claims utilizing medical expertise, knowledge of CPT/diagnosis codes, CMC guideline along with referring to client specific guidelines and member policies 2. Adhere to the state and federal compliance policies and contract compliance 3. Assist the prospective team wit ...

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📑 JOB DETAILS 1. Prevent the payment of potentially fraudulent and/or abusive claims utilizing medical expertise, knowledge of CPT/diagnosis codes, CMC guideline along with referring to client specific guidelines and member policies 2. Adhere to the state and federal compliance policies and contract compliance<b ...

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📑 JOB DETAILS 1. Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions 2. Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating ...

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📑 JOB DETAILS 1) Evaluate health message scripts and content for clinical accuracy. 2) Check documents (mentioned above) developed by copywriters for clinical and scientific, reporting errors by checking the developed material against annotated references, clinical guidelines, other published sources data 3 ...

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📑 JOB DETAILS 1. Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions 2. Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on ass ...

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📑 JOB DETAILS 1) Creating and writing trial protocols, and presenting these to steering committee. 2) Identifying, evaluating and establishing trial sites, and closing sites down on completion of trial. 3) Training site staff on therapeutic areas, protocol requirements, proper source documentation and case report form completion. 4) Liaise with ...

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📑 JOB DETAILS 1) Creating and writing trial protocols, and presenting these to steering committee. 2) Identifying, evaluating and establishing trial sites, and closing sites down on completion of trial. 3) Training site staff on therapeutic areas, protocol requirements, proper source documentation and case report form completion. 4) Liaise with ...

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📑 JOB DETAILS 1) Creating and writing trial protocols, and presenting these to steering committee. 2) Identifying, evaluating and establishing trial sites, and closing sites down on completion of trial. 3) Training site staff on therapeutic areas, protocol requirements, proper source documentation and case ...

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📑 JOB DETAILS 1) Creating and writing trial protocols, and presenting these to steering committee. 2) Identifying, evaluating and establishing trial sites, and closing sites down on completion of trial. 3) Training site staff on therapeutic areas, protocol requirements, proper source documentation and case ...

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📑 JOB DETAILS 1. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice (GCP) guidelines, and other applicable regulatory requirements. 2. Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and GCP gui ...

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📑 JOB DETAILS 1. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice (GCP) guidelines, and other applicable regulatory requirements. 2. Perform site selection, initiation, monitoring and close-out visits in accordance with con ...

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📑 JOB DETAILS 1) Performing the Case Analysis and Peer Review (Quality check) 2) Perform medical review (including verifying the coding & labeling, reviewing narratives, causality statement, medical aspect of follow-up request), validate follow-up request and perform medical assessment of the case for the Catego ...

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📑 Responsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) for1) New Drug Applications (NDA), Biologic Licensing Applications (BLA), Marketing Authorization Applications (MAA) and supplemental NDAs/BLAs/ Type II variations, 2) for related follo ...

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📑 Responsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) for1) New Drug Applications (NDA), Biologic Licensing Applications (BLA), Marketing Authorization Applications (MAA) and supplemental NDAs/BLAs/ Type II variations,2) for related follow ...

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📑 Responsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) for 1) New Drug Applications (NDA), Biologic Licensing Applications (BLA), Marketing Authorization Applications (MAA) and supplemental NDAs/BLAs/ Type II variations, 2) for re ...

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📑 Responsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) for1) New Drug Applications (NDA), Biologic Licensing Applications (BLA), Marketing Authorization Applications (MAA) and supplemental NDAs/BLAs/ Type II variations,2) for relate ...

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📑 Position Title : Submission ManagerAbout The RoleResponsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) forNew Drug Applications (NDA), Biologic Licensing Applications (BLA), Marketing Authorization Applications (MAA) and supplemental NDAs/ ...

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📑 Position Title : Submission ManagerAbout The RoleResponsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) forNew Drug Applications (NDA) , Biologic Licensing Applications (BLA), Marketing Authorization Applications (MAA) and supplemental NDAs ...

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📑 JOB DETAILS 1 Develop and maintain in-depth knowledge for assigned product(s) / relevant therapeutic area(s) through attendance/ participation at key internal meetings/training sessions, relevant congresses, and seminars and by regular self-study of the national/international literature. 2 Provide expert medic ...

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📑 Position Title : Submission Manager About The Role Responsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) for New Drug Applications (NDA) , Biologic Licensing Applications (BLA), Marketing Authorization Applications (MAA) and supplemental ...

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📑 Position Title : Submission ManagerAbout The RoleResponsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) forNew Drug Applications (NDA) , Biologic Licensing Applications (BLA), Marketing Authorization Applications (MAA) and supplemental NDAs ...

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📑 Position Title : Submission ManagerAbout The RoleResponsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) forNew Drug Applications (NDA) , Biologic Licensing Applications (BLA), Marketing Authorization Applications (MA ...

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📑 Position Title : Submission ManagerAbout The RoleResponsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) forNew Drug Applications (NDA) , Biologic Licensing Applications (BLA), Marketing Authorization Applications (MAA) and suppl ...

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📑 Position Title : Submission ManagerAbout The RoleResponsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) forNew Drug Applications (NDA) , Biologic Licensing Applications (BLA), Marketing Authorization Applications (MA ...

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📑 Position Title : Submission ManagerAbout The RoleResponsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) forNew Drug Applications (NDA) , Biologic Licensing Applications (BLA), Marketing Authorization Applications (MA ...

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📑 Your responsibilities include, but are not limited to:May lead studies in maintenance or in closeout phase or ongoing studies post primary database lock with the oversight of the LCTL/CTL, as assigned. Support the clinical protocol development process in collaboration with the CTL/Lead CTL and the Clinical program Leader (CPL): chip in to the devel ...

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📑 Position Title : Submission Manager About The Role Responsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) for New Drug Applications (N ...

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📑 About The RoleYour responsibilities include, but are not limited to:Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol.Support the assessment of new data collection requirements in assigned studies and provide clinical input into the development of ne ...

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📑 About The RoleYour responsibilities include, but are not limited to:Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol. Support the assessment of new data collection requirements in assigned studies and provide clinical input into the development of n ...

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📑 Your responsibilities include, but are not limited to:May lead studies in maintenance or in closeout phase or ongoing studies post primary database lock with the oversight of the LCTL/CTL, as assigned. Support the clinical protocol development process in collaboration with the CTL/Lead CTL and the Clinical program Leader (CPL): chip in to the ...

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📑 About The RoleYour responsibilities include, but are not limited to:Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol.Support the assessment of new data collection requirements in assigned studies and provide clinical input into the devel ...

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📑 About The RoleYour responsibilities include, but are not limited to:Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol.Support the assessment of new data collection requirements in assigned studies and provide clinical input into the devel ...

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📑 About The RoleYour responsibilities include, but are not limited to:Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol. Support the assessment of new data collection requirements in assigned st ...

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📑 Your responsibilities include, but are not limited to:•Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol.•Support the assessment of new data collection requirements in assigned studies and provide clinical input into the development of new and update ...

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📑 Your responsibilities include, but are not limited to:•Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol.•Support the assessment of new data collection requirements in assigned studies and provide clinical input into the development of new and update ...

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📑 Your responsibilities include, but are not limited to:•Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol.•Support the assessment of new data collection requirements in assigned studies and provide clinical input into the development of new an ...

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📑 Your responsibilities include, but are not limited to:•Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol. •Support the assessment of new data collection requirements in assigned studies and provide clinical input into the developm ...

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📑 Your responsibilities include, but are not limited to:•Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol.•Support the assessment of new data collection requirements in assigned studies and provide clinical input into the development of new an ...

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📑 Senior/Lead Statistical Programmer Full-Time Bengaluru, Karnataka, India Hyderabad, Telangana, India Description Job Responsibilities: • Annotate Case Report Form ( following FDA/CDISC or sponsor guidelines. • Develop SDTM specifications and generate SDTM datasets using SAS. • Develop ADaM specifications and generate ADaM datas ...

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📑 Senior/Lead Statistical ProgrammerFull-TimeBengaluru, Karnataka, IndiaHyderabad, Telangana, IndiaDescriptionJob Responsibilities:• Annotate Case Report Form ( following FDA/CDISC or sponsor guidelines.• Develop SDTM specifications and generate SDTM datasets using SAS.• Develop ADaM specifications and generate ADaM datasets using SAS based on Statis ...

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📑 Senior/Lead Statistical ProgrammerFull-TimeBengaluru, Karnataka, IndiaHyderabad, Telangana, IndiaDescriptionJob Responsibilities:• Annotate Case Report Form ( following FDA/CDISC or sponsor guidelines.• Develop SDTM specifications and generate SDTM datasets using SAS.• Develop ADaM specifications and generate ADaM datase ...

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📑 Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of clinical trial documentation and datasets. You will collaborate wi ...

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📑 Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of clinical trial documentation and datasets. You will collaborate wi ...

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📑 Associate Clinical Data ManagerSDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop ...

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📑 Senior/Lead Statistical Programmer Full-Time Bengaluru, Karnataka, India Hyderabad, Telangana, India Description Job Responsibilities: • Annotate Case Report Form ( following FDA/CDISC or sponsor guidelines. • Develop SDTM specifications and generate SDTM dat ...

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📑 Position Title :Senior Transparency AssociateAbout the role :Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of clini ...

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📑 Position Title :Senior Transparency AssociateAbout the role :Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of clini ...

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📑 Position Title : Senior Transparency Associate About the role : Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of cl ...

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📑 Position Title :Senior Transparency AssociateAbout the role :Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of clini ...

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📑 As a Clinical Research Associate, you'll play a pivotal role in ensuring the successful execution of clinical trials. From monitoring trial progress to ensuring regulatory compliance and participant safety, you'll be at the forefront of cutting-edge medical research.Key Responsibilities:Conduct site visits to monitor trial activities and ensure com ...

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