3474 Clinical Trials Jobs - Page 34

The Senior Analyst role in Bristol Myers Squibb s Trial Analytics, Insights, and Planning (TAIP) unit is an excellent opportunity for professionals with approximately 3-6 years of experience in consulting, life sciences analytics, or clinical trial operations to step into an internal consulting environment that directly accelerates drug development. Senior Analysts join one of two tracks based on their background and preference: The Analytical track focuses on forecasting, data modelling, dashboards, and site performance analytics. The Scientific track focuses on protocol logic, patient population sizing, eligibility criteria, and feasibility planning. Regardless of track, you will gain expo...

Provide strategy, oversight and tactical support of Document Management run the business activities. Including document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement. Support health and performance of associated electronic management systems in compliance with procedural guidelines. Manage stakeholder needs in balance to priorities and execution of document procedural adherence. Ensure up to date monitoring of review and approval ownership to prevent deviation of effectiveness for global document management and health authority requirement adherence. Manage events associated to findings of compliance gaps and de...

The Annual Product Review (APQR) Manager Will primarily manage the Global BMS site APQR program by authoring and completing the APQRs for all BMS commercial Marketed Products. The APQR manager will be responsible for the completion of this annual compliance expectation by partnering with the site to draft and compete document from final approval. The APQR specialist will be responsible for the following defined roles and responsibilities: Responsible to provide oversight and completion of the site APQRs Responsible for authoring through approval of APQRS assigned, per site APQRs per schedule Responsible for ensuring any site or CMO APQR is created following the effective process and procedur...

Provide high-level administrative support to the GQCC team, including senior leaders and large teams. Support the onboarding process for new team members, including arranging equipment, access, and training. Manage complex calendars, schedule meetings, and coordinate appointments across multiple time zones. Arrange travel itineraries, including flights, accommodations, and transportation, ensuring cost-effectiveness and adherence to company policies. Prepare and edit correspondence, presentations, reports, and other documents using MS Office Suite. Coordinates both individual and departmental meetings, off-site activities and meetings with vendors/suppliers; provides support for meetings by ...

Roles and Responsibility Develop and implement operational strategies to achieve business objectives. Manage and supervise a team of professionals to ensure efficient operations. Analyze operational data to identify areas for improvement and optimize processes. Collaborate with cross-functional teams to align with organizational goals. Ensure compliance with regulatory requirements and industry standards. Foster a culture of continuous improvement and excellence within the team. Job Requirements Proven experience in operations management with a minimum of 8 years of experience. Strong leadership and management skills, with the ability to motivate and inspire teams. Excellent analytical and p...

Roles and Responsibility Develop and implement operational strategies to achieve business objectives. Manage and supervise a team of professionals to ensure efficient operations. Analyze operational data to identify areas for improvement and optimize processes. Coordinate with various departments to ensure seamless operations and resolve issues. Implement and maintain quality control measures to ensure high standards. Identify and mitigate risks to ensure compliance with regulatory requirements. Job Requirements Proven experience in operations management with a minimum of 5 years of experience. Strong knowledge of operational principles and practices. Excellent leadership, communication, and...

Key Responsibilities: Develop, implement, and maintain robust financial crime prevention policies and procedures, including anti-money laundering (AML), fraud, sanctions compliance, and counter-terrorism financing (CTF). Lead and manage financial crime risk assessments and due diligence processes. Oversee investigations related to suspicious activities, ensuring timely escalation and resolution. Ensure compliance with applicable laws, regulations, and industry standards. Coordinate with internal departments and external regulators on compliance issues. Monitor and report on regulatory changes and implement necessary adjustments. Provide training and awareness programs on financial crime and ...

Lead and coordinate internal and external pharmacovigilance audits of the BMS PV System and its Quality System (including Critical processes, Affiliates, Licensing Partners, Service Providers/Vendors, Distributors, and NI PASS) to ensure compliance with regulatory requirements, company procedures and contractual arrangements. Document audit findings and prepare detailed audit reports in line with procedural timelines. Support and advise on the development of appropriate corrective and preventive actions. Proactively manage findings, responses and CAPA arising from audits in the BMS Quality Management system. Review the effectiveness of actions to address audit findings. Maintain expertise in...

Responsible to provide oversight and completion of the site APQRs Responsible for authoring of APQRS assigned, per site APQRs per schedule Responsible for ensuring any site or CMO APQR is created following the effective process and procedures Provide in depth quality and compliance oversight during report authoring. Responsible for ensuring all elements of the AQPR procedure are fulfilled accurately. Responsible for facilitating review and approval meetings, problem-solving key issues, and effectively managing communications with key stakeholders. Responsible for collecting review feedback and resolving comments and questions. Responsible for projecting and communicating stakeholder actions ...

With appropriate support and guidance, provide statistical support for the production and checking of statistical outputs and the development of analysis plans, under the direction of the project team lead. Essential Functions Production of High-Quality Deliverables: Completes, and reviews, assignments on time. Clearly follow instructions of project lead in the execution of project assignments. Seeks assistance and guidance when needed. AIQVIA for Right the First Time. Timelines and Communication: Attends internal project team meetings. Accountable for speaking up if a task takes longer than expected to complete. Provides timely progress updates to team lead. Supports colleagues as requested...

Company Description At Novaspire, we pride ourselves on being a trusted partner to the pharmaceutical industry, dedicated to delivering comprehensive, high-quality clinical research services. We support pharmaceutical, biotechnology, medical device, and nutraceutical companies at every stage of the product development lifecycle, from Phase I clinical studies to post-market surveillance. Our core services include pharmacovigilance, clinical trials, medical writing, bioequivalence study support, GxP consulting services and training, and imaging studies. We are committed to ensuring patient safety, regulatory compliance, and high-quality data to enhance clinical trial outcomes. Role Description...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with AML and Fraud mgmt experience.Understand & implement laws, and regulations designed to stop the practice of generating income through illegal actions during transfer of funds. Anti Money Laundering law covers limited number of transactions and criminal behaviors to prevent terrorist financin...

About The Role Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP HCM Payroll Good to have skills : asp net Minimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in pr...

About The Role Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Specialist Qualifications: BE/BTech/BSc Years of Experience: 7 to 11 years Language - Ability: English(Domestic) - Intermediate What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life...

QA review and approval of validation deliverables associated with various BMS enterprise systems, including but not limited to clinical study databases, electronic Case Report Forms (eCRFs), enterprise commercial manufacturing systems such as electronic laboratory notebooks and manufacturing execution systems, ERP systems including SAP and Oracle, Veeva-based systems such as Clinical Trial Management Systems (CTMS), electronic Trial Master File (eTMF), Regulatory Information Management (RIM), and Quality Management Systems (QMS), as well as various Veeva Vault-based configurations. Ensure adequate and timely quality assurance / regulatory compliance support Provide support during regulatory ...

Help to develop the Quality Narrative at a study and TA level, to document the end-to-end risk-based quality management for critical to quality (CtQ) data, processes and vendors demonstrating effective risk and issue management. This will involve collecting all the relevant inputs from the Risk Based Monitoring (RBM) framework Clinical Oversight and Risk Management (CORM) as well as R&D Quality Clinical Quality Assurance on audits and inspections. Work with Drug Development, particularly the CORM function, to embed Quality by Design principles and help identify study specific CtQ data, processes and vendors and ensure adequate risk mitigation strategies have been implemented. Provide feedbac...

Identify opportunities for process improvements by analyzing current workflows, systems, and procedures related to CAPA management. Lead cross-functional teams to drive process improvement projects from inception to completion. Manage the CAPA process, including the identification, investigation, and resolution of non-conformances. Act as a CAPA lead investigator to conduct and manage root cause analysis, perform impact assessment of GCP deviations, audits (investigator sites, protocols, process, vendors, systems, and others as required), inspections, quality events and serious breaches. Act as a subject matter expert (SME) to support the business develop robust CAPAs with adequate effective...

Ensure adequate and timely quality assurance / regulatory compliance support Provide support during regulatory agency and third party inspections Research new technologies, understand existing processes, and reference recognized standards and frameworks Pursue continuous professional development through company paid internal/external training, certifications and/or continuing education. Identify opportunities for continuous improvement Adherence to BMS Core Behaviors Conduct risk & impact assessment to determine the extent of validation and qualification and ensure right sized validation effort for programs Demonstrate critical thinking around interpreting business and industry challenges an...

About The Role Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP HCM Payroll Good to have skills : NA Minimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in problem-...

Assist Data Management Study Lead in development of eCRF, Data Validation Specifications, and Study Specific Procedures. Review clinical and third-party data based on edit specifications and data review plans. Issue clear, accurate, and concise queries to investigational sites. As required, communicate effectively with peers, clinical data scientist and functional management. Perform other project activities as required in order to ensure that study timelines are met (for example, filing and archiving of study documentation, dispatching of queries to investigator sites for resolution, etc.). Your profile Bachelors degree in a relevant field, such as Life Sciences or Healthcare. Basic kNwledg...

Exchange and dissemination of scientific, educational, and research related information: The MSL plans, prepares and engages with Thought Leaders (TLs Doctors) as an information scientist and colleague both proactively and reactively via various innovative TL engagements tactics and formats. MSLs provide dissemination, clarification and education of scientific data, study protocols, meeting abstracts, and professional literature (both proactive discussions on-label, and reactive discussions for unsolicited off-label questions in alignment with local regulations). Interactions with Medical Societies and Advisory Boards: The MSL answers medical / scientific queries of Medical Societies with re...

Support AI application deployment workflows using Docker containerization, CI/CD pipelines and API based inference services Implement observability of AI functionality executions through logging, monitoring and tracing Perform code reviews, functional testing and model optimizations Stay updated on AI / ML tool advancements within AWS and relevant industry best practices Overview Emmes Group: Building a better future for us all Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US gover...

JOB DESCRIPTION Job Title: Lead Biostatistics and Clinical Data Management Job Location: Bangalore About Syngene : Syngene ( www. syngeneintl. com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and pro...

Job Title: Global Study Supply Support (GSSS) Role Overview Provide operational support to Clinical Supply Chain Study Leaders for multiple studies across all phases (set-up, follow-up, closure). Work independently and collaborate with multiple leaders and cross-functional teams. Key tasks include: Preparing and tracking transfer orders. Managing stock reconciliation. Performing quality checks. Preparing documentation for labeling and shipments. Monitoring needs for destruction. Archiving documents in the electronic Trial Master File. Key Responsibilities Support clinical supply chain operations for global studies. Ensure compliance with regulatory standards and protocols. Maintain accurate ...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving cus...