652 Clinical Trials Jobs - Page 21

As a Senior Clinical Transparency Lead you will be joining the worlds largest & most comprehensive clinical research organisation, powered by healthcare intelligence, What You Will Be Doing Assesses requirements for clinical trial registration / disclosure of results or public disclosure strategy plans, Prioritizes, oversees, and performs the day-to-day operations of Clinical Transparency or Public Disclosure, ensuring the timely completion, review and approval of registration, updates and results disclosure activities, Manages the review and approval process for clinical trial registrations or public disclosure tracking mechanisms, including communication with partner companies or collaborators, Facilitates periodic review of active registrations or public disclosure strategy plans to ensure records are updated or verified as required, Uses independent judgment to assess clinical transparency or public disclosure activities and problem solving to determine escalation of issues to management, Coordinates and oversees the work of consultants and vendors as applicable, Addresses inquiries related to clinical transparency or public disclosure activities, Provides feedback to Clinical Transparency or Public Disclosure leadership resulting from new and updated transparency requirements, Leads retrospective review to ensure compliance of trials resulting from new clinical transparency or public disclosure knowledge or requirements, Develops training materials, reference documents and tools for use with clinical transparency or public disclosure activities, Educates study or asset team members and other organizational contacts on clinical transparency or public disclosure policies and processes, Establishes and maintains global working relationships, Communicate changes throughout the client organization, Work cross-functionally to improve processes and address changes, Evaluate process automation, systems, and tools to improve efficiency, accuracy, and productivity, Lead clinical transparency or public disclosure training for global colleagues, You Are Bachelors Degree, or equivalent experience required, 5 years pharmaceutical industry experience required with experience in Transparency and/or Disclosure activities Working knowledge of clinical drug development and clinical trial protocols Excellent organizational skills and high attention to detail, Self-directed and motivated, with ability to work without significant direct supervision, asking questions when necessary, Ability to manage multiple tasks and readily switch activities to accommodate priority needs, Proficient computer skills, including experience with MSWord and Excel, Healthcare professional background preferred, What ICON Can Offer You Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent, In addition to your competitive salary, ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family, Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers iconplc /benefits At ICON, inclusion & belonging are fundamental to our culture and values Were dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status, If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below, https://careers iconplc /reasonable-accommodations Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles,

ICON plc is a world-leading healthcare intelligence and clinical research organization Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development, Job Title: Senior Lead Clinical Data Science Programmer [Elluminate] Location : Chennai/ Bangalore What You Will Be Doing Develop, implement and maintain date review and data cleaning capabilities for sponsors led Phase I-IV clinical trials using sponsors technologies in support of efficient study execution and related decision-making including incorporation of emerging approaches to such activities Contributes to related technical and/or process improvement initiatives associated with data reporting and analytics across DS and Astellas broadly Collaborates with any vendors providing data reporting and analytical capabilities and/or support for such capabilities Collaborates cross functionally to ensure that any issues with the data reporting and analysis are addressed as appropriate You Are BS or MS degree, preferably in Computer Science, Informatics/Data Science, or life science discipline Prior pharma or CRO industry experience working on global clinical studies and projects or global process and system initiatives Prior experience in Reporting [Elluminate or Cluepoint] Strong verbal and written communication skills What ICON Can Offer You Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent, In addition to your competitive salary, ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family, Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers iconplc /benefits At ICON, inclusion & belonging are fundamental to our culture and values Were dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status https://careers iconplc /reasonable-accommodations Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles,

ICON plc is a world-leading healthcare intelligence and clinical research organization Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development, Job Title: Clinical Data Enablement Data Aggregation Lead Location : Chennai/ Bangalore What You Will Be Doing Enable the data flow for Phase I-IV clinical trials consistent with aligned commitments inclusive of data ingest, transformation and internal availability of this data for data review, data cleaning and readiness for data analysis Works directly with vendors providing source data (i-e vendors providing lab results, ECGs, biomarkers, etc ?) and/or internal functions such as clinical operations or early development to ensure that related specifications, mechanisms for data transfers and data transfer schedules are established and executed appropriately Contributes to related technical and/or process improvement initiatives associated with the clinical results data flow and efforts within the department and across sponsors broadly Collaborates with vendors providing capabilities and/or support for the clinical data flow to ensure successful delivery of study level data Collaborates cross functionally with areas performing data management, clinical operations, IT support, etc to address any issues with the delivery or stability of the clinical data flow as appropriate You Are BS or MS degree, preferably in Computer Science, Informatics/Data Science, or life science discipline Prior pharma or CRO industry experience working on global clinical studies and projects or global process and system initiatives Prior experience with systems and processes that include an end-to-end data flow and the transformation of data in support of data review and/or data cleaning Strong verbal and written communication skills What ICON Can Offer You Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent, In addition to your competitive salary, ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family, Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers iconplc /benefits At ICON, inclusion & belonging are fundamental to our culture and values Were dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status, https://careers iconplc /reasonable-accommodations Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles,

Let s do this. Let s change the world. In this vital role you will coach who facilitates team with Scrum events, processes, and supports teams in delivering value for Clinical Data Management and Interactive Response Technology (CDM-IRT) Systems Team. The role involves facilitating communication and collaboration among teams, ensuring alignment with the program vision, handling risks and dependencies, and driving relentless improvement. The Scrum master help adapt SAFe to the organization s needs, standardizing and documenting practices. The role requires a solid background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. Roles & Responsibilities: Lead and handle product delivery using agile frameworks and techniques. Align with Agile values such as prioritizing individuals and interactions over processes and tools. for Clinical Data Management and Interactive Response Technology (CDM-IRT) Systems Team Ensure Day-to-Day operations by automating tasks, monitoring system health, and minimizing downtime through incident response Capture the voice of the customer to define business processes and product needs Collaborate with CDM-IRT business stakeholders, Architects and Engineering teams to prioritize release scopes and refine the Product backlog Lead and facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team Clearly express features in User Stories/requirements so all team members and stakeholders understand how they fit into the product backlog Ensure Acceptance Criteria and Definition of Done are well-defined Advise SAFe events, including PI Planning, Scrum of Scrums, and Inspect & Adapt workshops. Stay focused on software development to ensure it meets requirements, providing proactive feedback to stakeholders Help develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements Identify and manage risks associated with the systems, requirement validation, and user acceptance Develop & maintain documentations of configurations, processes, changes, communication plans and training plans for end users Ensure operational excellence, cybersecurity, and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Develop a culture of collaboration, innovation, and continuous improvement What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree with 4 - 6 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR Bachelor s degree with 6 - 8 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR Diploma with 10 - 12 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies Preferred Qualifications: Must-Have Skills Solid grasp of Agile methodologies, particularly the Scaled Agile Framework (SAFe) Prior experience with Agile project management tools, such as Jira, Confluence and Jira Align Experience in guiding teams through Agile events and ensuring adherence to SAFe practices and behaviors Familiarity with regulatory requirements for Clinical Trials (e. g. 21 CFR Part11, ICH, HGRAC) Good-to-Have Skills: Experience in handling product features for PI planning and developing product roadmaps and user journeys Experience maintaining SaaS (software as a system) solutions and COTS (Commercial off the shelf) solutions Technical thought leadership Able to communicate technical or complex subject matters in business terms Professional Certifications (please mention if the certification is preferred or required for the role): Certified SAFe Scrum Master or similar (required) ITIL (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours.

Let s do this. Let s change the world. In this vital role you will leverages domain, technical and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans. This role involves working closely with business stakeholders, system owners and security analysts to ensure technical requirements are collated, documented and implement to ensure the success of our internal and external business partners. You will collaborate with the Product Owner and other Business Analysts to maintain an efficient and consistent process, ensuring the best quality deliverables from the team. Roles & Responsibilities: Build strong relationship with key business leads and external partners to ensure their needs are being met Own expedited resolution of business-critical issues affecting the delivery of key external business partners Work with Product owner and business stakeholders to collected details requirements and user stories Analyze technical and business problems and work with cross-functional owners to develop long-term solutions Maintain accurate documentation of configurations, processes, and changes Own technical solutions and maintain detailed system and user documentation What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of Life Science / Biotechnology / Information Systems experience OR Bachelor s degree and 3 to 5 years of Life Science / Biotechnology / Information Systems experience OR Diploma and 7 to 9 years of Life Science / Biotechnology / Information Systems experience Preferred Qualifications: Must-Have Skills: Customer focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on technology topics Experience of working with or supporting systems used to execute clinical trial. E. g. Rave, CTMS, Veeva Experience of working with or in a Clinical Research Organizations (CROs) or other specialist suppliers supporting clinical trials Experience with Agile software development methodologies (Scrum), Change management and problem management Excellent problem-solving skills and a committed attention to detail in finding solutions. Good-to-Have Skills: Knowledge of network security protocols and tools (e. g. , IPSEC, SSL, IDS/IPS, firewalls) Experience of O365 Cloud PC VDI Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Highly organized and able to work under minimal supervision Skilled in providing oversight and mentoring team members. Excellent analytical and gap/fit assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Familiarity with GxP, CFR 21 Part 11 and systems validation Ambitious to further develop their skills and career

Let s do this. Let s change the world. In this vital role you will leverages domain, technical and business process expertise to provide exceptional end user support of Amgen s external suppliers to ensure their effectiveness to deliver Amgen clinical trials for Amgen study teams. This role involves working closely with internal and external business stakeholder and support analysts to ensure rapid resolution of technical issues, performing route cause analysis and implementation of long-term preventative solutions. You will collaborate with the Product Owner and a team of other Business Analysts to ensure operational support excellence from the team. Roles & Responsibilities: Build strong relationship with key business leads and external partners to ensure their needs are being met Oversee expedited resolution of business-critical issues affecting the delivery of key external business partners Work with Product owner and business stakeholders to collected details requirements and user stories Analyze technical and process problems and work with multi-functional owners to develop solutions Maintain accurate documentation of configurations, processes, and changes Maintain detailed system and user documentation What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a with these qualifications. Basic Qualifications: Bachelor s degree and 0 to 3 years of Life Science / Biotechnology / Information Systems experience OR Diploma and 4 to 7 years of Life Science / Biotechnology / Information Systems experience Preferred Qualifications: Must-Have Skills: Customer focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on technology topics Experience of working with or supporting systems used to execute clinical trials. E. g. Rave, CTMS, Veeva Excellent problem-solving skills and a committed attention to detail in finding solutions Good-to-Have Skills: Experience of working with or in a Clinical Research Organizations (CROs) or other specialist suppliers supporting clinical trials Experience with Agile software development methodologies (Scrum) Knowledge of network security protocols and tools (e. g. , IPSEC, SSL, IDS/IPS, firewalls) Experience of O365 Cloud PC VDI Professional Certifications : SAFe for Teams certification (preferred) Soft Skills: Highly organized and able to work under minimal supervision Excellent analytical and assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Familiarity with GxP, CFR 21 Part 11 and systems validation Ambitious to further develop their skills and career

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. The Manager, Alliance Accounting, is a key member of the Global Finance organization, supporting the management team in the global consolidation, financial, and external reporting processes. This role involves interacting with our external partners and BMS colleagues across various regions and functions to manage our license and collaboration agreement obligations. The position offers substantial exposure to pharmaceutical industry accounting and reporting practices, enhancing financial reporting and analysis skills, communication skills, and leadership abilities in a global environment. Duties and Responsibilities: Execute monthly and quarterly accounting processes, collaborating with external and internal stakeholders by preparing journal entries, performing balance sheet reconciliations, reporting of results to external and internal partners and managing cash activity. Prepare quarterly royalty statements in compliance with license and collaboration agreements, ensuring accuracy and meeting reporting deadlines. Identify and resolve discrepancies or issues related to royalty reports and payments. Participate in cross-functional projects and support other finance organization teams as needed. Provide support for internal and external audits and control tests related to royalties and alliance practices. Champion process improvement and automation initiatives within the controllership organization Analyze and implement changes to corporate reporting systems, processes, reports, and controls to align with the company s evolving business models. Requirements: 5+ years of accounting experience, preferably with a focus on US GAAP. University degree in Accounting CA (Chartered Accountant) required Public company experience strongly preferred. Exposure to collaboration and license arrangements preferred. Advanced Microsoft Excel skills, including the ability to manipulate large data sets. Experience in the Pharmaceutical/Life Sciences/Biotech industry preferred. Strong analytical skills and critical thinking skills. Ability to prioritize and manage workloads in a complex work environment. Team player with a process-oriented mindset. Accountable, self-motivated, and results-oriented, with a strong sense of ownership. Highly organized, accurate, and detail-oriented, with the ability to manage multiple projects simultaneously, work under pressure, and meet tight deadlines. Excellent communication skills, with the ability to work well with all levels and departments within the company. Working knowledge of SAP and SAP Business Consolidation Systems preferred. Ability to thrive in a fast-growing environment with frequent changes, requiring strong multi-tasking skills and flexibility. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Perform comprehensive data management tasks, Validation, Data transfers and quality control procedures. Provide Clinical Data Management team with technical expertise. Perform tasks as communicated by TL/LDM Create/review the Data Management Plans Required Candidate profile Graduate/Postgraduate in Computer Science/Computer Application/Physics/Math/Life Sciences/Pharmacy 2-8 years of experience in Statistical (SAS) programming International BPO experience is mandatory

Proud to be recognized as one of Forbes Americas Best Startups! Also proud to be recognized as a Most Loved Workplace! Enveda is looking for a Director, Medicinal Chemistry to join our team in Hyderabad, India The contribution you will make: We are looking for a Director, Medicinal Chemistry with a demonstrated track record ofdelivery of optimized leads and clinical candidates for advancing them into human clinical trials. You will lead medicinal chemistry activities for two or more projects in parallel. You will be involved in identifying pre-leads, design and optimization of leads for potency, selectivity and druggability and also strong IP generation. You will recruit PhD and M. Sc. synthetic chemists and mentor them as medicinal chemists and manage their performance and improve their productivity. You will collaborate with your peers in Medicinal Chemistry and work as a team to increase delivery of compounds to the Clinical Pipeline of Enveda. You will also collaborate with Senior Leaders in other functional departments such as ADME, Analytical Sciences and Pharmacology and deliver high value molecules to Enveda. As a member of the broader Drug Discovery team, you will report to the VP, Discovery Chemistry. You get to collaborate on Medicinal Chemistry of Lead Generation and Lead Optimization of Pipeline Projects. Understand Structure Activity Relationships and Structure Property Relationships of various projects. Collaborate with Medicinal Chemistry, Pharmacology, Analytical, ADME, Tox, IP, Site and Global Leadership. Develop appropriate flow schemes with relevant in vitro, in vivo, ADME/PK and tox studies. Appropriate allocation of resources for maximum cost effectiveness. Work effectively with Project ManagementMake presentations of your projects at various Enveda forums. You work with the site safety head and emphasize the importance of safe practices in the chemistry laboratories Who will thrive in this role? Doctor of Philosophy in Synthetic Organic Chemistry15-20 years of post-PhD experience in Medicinal ChemistryProven track record of delivery of leads and clinical candidates to the pharmaceutical industry. Management and mentoring of synthetic chemists. Good understanding of intellectual property of medicinally valuable compounds with respect to composition of matter, method of use and chemical processes. Strong understanding of safety practices in organic synthesis laboratories. If you dont meet all of the requirements listed here, we still encourage you to apply. No job description is perfect, and we might find an even more suitable opportunity that matches your experience. What to expect in the interview process: HR Screen (30 minutes) Hiring Manager Interview (45 minutes) Work Sample Interview (60 minutes)T echnical Interview (60 minutes) Enveda Culture Interview (45 minutes) Some of the total rewards of working here Culture: Enveda lives for people Healthcare: Medical insurance premium for coverage of the employee, spouse, and kids is fully sponsored by the company. The premium for coverage of dependent parents is partially sponsored by the company (at 50%). PTO: Block leaves (that we encourage and celebrate) and company-wide weeklong break to recharge in addition to 8 observed holidays. Work-Life Harmony Come join us! Our employees are the lifeblood of our work and our inspiration to press on. Together weve built a special place here a drug discovery platform thats unique in the world with an incredible team collaborating in a creative, transformative culture. Our mission is to bring hope to patients everywhere. Our progress towards that goal would not be possible without talented people like you. Employee Promise Using our imagination and dedication, we are working to improve human health and give hope to patients everywhere. Our work together is empowering, trustable and collaborative, enabling you to do your best work. Envedas values Curiosity : Learn and challenge. Agency : Own and initiate. Journey : Love the process. Charity : Take care of each other. Unity : We are one Enveda. We value your uniqueness One of lifes gifts is to interact with a variety of people. Each of us has a unique story that shapes how we view the world, and solve problems. Learning from each other enhances our collective wisdom while achieving better outcomes at a faster clip. People from all kinds of backgrounds can succeed in all kinds of roles. Our work environment appreciates the contributions of every person. Working together is how we produce results that illuminate our Purpose - To Deliver Hope To Every Patient. Unity is a company value because success depends on trusting, working relationships that respect the commonality and differences of people. At Enveda we are building a place where every person can do the best work of their lifetime. Enveda is an equal opportunity employer. We do not discriminate on the basis of characteristics protected by federal, state or local laws. *Please note jobs may be taken down from our website, this does not mean they have been filled. This is to maintain our candidate experience for current applicants. If you are in the interview process and would like to request a copy of the job description, reach out to your recruiting contact.

Let s do this. Let s change the world. Job Description The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Electronic Data Interchange/Acquisition programming activities. The Manager, CSAR - Electronic Data Interchange and Acquisition will develop the Data Acquisition Requirements Specification (DARS) document to outline metadata transfer requirements, establish and validate vendor integration criteria, and manage the processing of electronic data from vendors. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. Manager, CSAR - Electronic Data Interchange and Acquisition will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e. g. , Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in writing the Data Acquisition Requirements Specification (DARS) document to specify metadata transfer requirements, setting up and testing RWS integration requirements supporting study closure with final data loads and transfer discontinuation, configuring data upload gateways between external vendors and Amgen. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). What we expect of you We are all different, yet we all use our unique contributions to serve patients. Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Experienced in collecting, maintaining, aggregating, and supporting data cleaning controls for external (non-EDC) data, importing clinical study data from various sources including central labs and imaging vendors. Systems development lifecycle Programming Languages Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related field with 9-13 years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena Proven experience in managing teams General project management and planning experience Experience in oversight of outside vendors (CRO s, central labs, imaging vendors, IRT vendors, etc. ) Basic Qualifications Bachelor s degree or equivalent in life science, computer science, business administration or related field with 9-13 years of experience. Proven experience in managing teams Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

>To connect top practitioner doctors of different specialist all over India >To structure a proper process to establish & conduct medical survey for research & strategy purpose > Establish a proper compliance & register for conducting clinical trials

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage

Job description Should have knowledge in clinical research studies Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) should have knowledge in ICH GCP Guidelines Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

About the job: Key responsibilities: 1. Counsel patients to create better health outcomes. 2. Advertise the service and provide quality leads. 3. Understand oncology medications and can dispense drugs as prescribed by the treating oncologist. 4. Maintain patient care database by entering new information as it becomes available. 5. Maintain the operation of the unit dose area and drug mixing room. 6. Work on competent dispensing of medications per procedures and laws. 7. Verify findings and reports for backing up data. 8. Maintain quality service by establishing and enforcing organizational standards. 9. Maintain professional and technical knowledge by attending educational workshops. Who can apply: Only those candidates can apply who: have minimum 1 years of experience are from Sangareddy only Salary: ₹ 2,55,000 - 3,65,000 /year Experience: 1 year(s) Deadline: 2025-06-19 23:59:59 Other perks: Health Insurance Skills required: MS-Excel, Report Generation and Clinical Trials Other Requirements: 1. Effective communication skills. 2. Knowledge of MS-Excel, MS-Office, and PCI Licence. About Company: CIPHER vision is to reduce cancer-related mortality in India by empowering individuals to take control of their health and by helping them make informed decisions for a healthier life. CIPHER believes in not letting cancer take control of one's life. Our services are designed to support cancer patients and their guardians through emotional and practical concerns they may have. We hope that anyone affected by cancer now knows they can turn to us for assistance.

Role & responsibilities Study Site Management & Regulatory Compliance Conducting initiation visits to ensure sites are prepared for the trial. Regularly visiting study sites to ensure compliance with the protocol, Good Clinical Practice (GCP), and regulatory requirements. Ensuring that the study is conducted in accordance with the approved protocol and amendments. Verifying that informed consent is obtained from all study participants. Data Quality and Integrity Risk Management Implementing corrective and preventive actions (CAPA) to resolve issues and prevent recurrence. Documentation and Reporting - Ensuring all trial-related documentation is complete, accurate, and up-to-date. Preparing monitoring reports, site visit reports, and other required documentation. Patient Safety and Rights - Monitoring and reporting adverse events and serious adverse events (SAEs) in accordance with regulatory requirements. Ensuring the safety and well-being of study participants throughout the trial. Preferred candidate profile Masters in Science / PHD / Relevant qualification in Clinical Research Mandatory to have: Should have lead a team of CRC in past for minimum 3 - 4 years Perks and benefits Best in Industry

Department- Commercial, GBS Are you passionate about taking your competitive intelligence journey to next level? Do you want to work for a globally renowned organization Novo Nordisk? We are seeking a Global Competitive Intelligence Associate Lead to join our vibrant and fast-moving Commercial-GBS team in Bangalore, India. If that sounds like you, read on and apply today for a life-changing career. The position As a Global Competitive Intelligence Associate Lead at Novo Nordisk, you will be responsible for: Consistently track and monitor activities of pharmaceutical competitors and man-aging news on competitors from key scientific and clinical congresses within the TA, relevant for research, development projects, and brand strategies. Ensure timely monitoring, analysis, and communication of all relevant competitor activities to the stakeholders and establish comprehensive and up-to-date snap-shots of competitive landscapes in all areas, including competitor pipelines, projected approval timelines, and existing products. Provide regular updates with strategic implications for the company, highlighting new trends, market events, assessing landscapes, and unmet needs. Also, delivering focused deep dives on specific topics. Drive process to establish an overview of near, medium, and long-term challenges and opportunities posed to Novo Nordisk and offering ongoing assistance to relevant project teams. Lead coverage of major scientific congresses pertinent to therapy area for competitor activities. Qualifications We are looking for candidates with the following qualifications: A Masters degree in Life Sciences, Medicine, or Pharmaceutical Sciences. Over 8 years of experience in the Competitive Intelligence sector, specifically within the pharmaceutical industry. Ability to carry out daily responsibilities autonomously and skilled in staying updated with industry trends and therapy area knowledge, while adapting quickly. A strong understanding of essential aspects related to drug development and marketing. This includes knowledge in therapy areas, drug landscapes, disease comprehension, market insights, clinical and regulatory aspects, and recognizing forthcoming opportunities. Proven competence in effectively communicating scientific, technological, and commercial information to different organizational levels paired with a strategic mindset and analytical capabilities. A highly self-driven, proactive and organized approach, with excellent collaboration and communication skills when interacting with stakeholders across the global NN organization (Denmark and Bangalore). About the department The Commercial- GBS unit is responsible for driving deliverables for multiple Corporate Vice President (CVP) areas within Commercial- GBS. This includes Insulin, GLP-1 and Obesity Marketing, Market Access, Insights, and Commercial Operations. Located in Bangalore, India, our team is dynamic and fast-paced, working together to make a difference in the lives of patients worldwide.

Department- CMR (Clinical, Medical, Regulatory & Pharmacovigilance) Location- Bangalore / Hyderabad Are you an experienced medical professional and passionate about Clinical Medical? Does being part of a growing, yet dynamic environment excite you? If yes, then you may be the one we are looking for as Clinical Medical Manager for Novo Nordisk India. Apply now! The position As a Clinical Medical Manager, you will be responsible for : Facilitate the execution of clinical trials related to New Therapy Areas (including CVD, CKD, NASH) by providing medical/scientific expertise and advice. Identify and map KOLs, investigators, and research centres within the relevant therapy areas. Collect early scientific insights and guidance by discussing relevant early development data with external medical and scientific experts. Contribute to delivering successful clinical trials (phase I-IV) in collaboration with clinical operations. Provide timely medical guidance and internal training to clinical staff. Engage in extensive scientific communication both internally and externally, requiring strong presentation skills. Performing ad hoc visits, Supporting attendance at investigator meetings, ensuring KOL inclusion in clinical trials and engaging key investigators to communicate trial results. Qualifications To be successful in this role, you should have the following qualifications: MD in any discipline with a strong clinical research/medical affairs background. 5 years of clinical or pharmaceutical industry experience with strong experience in human healthcare research either from university, CROs, or pharmaceutical industry. Expertise in therapeutic areas of relevance (CVD, CKD, NASH), preferably with authorship in peer-reviewed journals. Understanding of pharmaceutical drug development. Open to domestic and international travel in connection with site visits, congresses, and company events. Experience as a clinical trial investigator or sub-investigator. Understanding the specificities and nuances of the local healthcare infrastructure. About the department The CMR (Clinical, Medical, Regulatory & Pharmacovigilance) team based in Bangalore. Our team is dedicated to driving clinical trials and providing medical/scientific expertise in New Therapy Areas. We work closely with KOLs, independent professional associations, and patient advocacy associations to ensure the successful execution of clinical trials. The atmosphere is collaborative and dynamic, with a strong focus on scientific excellence and patient outcomes.

Revenue Generation-development of new accounts/ existing accounts Client relationship Management Determine method and service that best meet client needs Executing the CDA/NDA, responding to RFI/RFP/RFQ/client queries Proposal Writing and budgeting

Job TitleLead Engineer (GPON) LocationBengaluru Work EmploymentFull time DepartmentPLM DomainSystem Engineering Reporting toManager/Senior Manager About Us: Tejas Networks is a global broadband, optical and wireless networking company, with a focus on technology, innovation and R&D. We design and manufacture high-performance wireline and wireless networking products for telecommunications service providers, internet service providers, utilities, defence and government entities in over 75 countries. Tejas has an extensive portfolio of leading-edge telecom products for building end-to-end telecom networks based on the latest technologies and global standards with IPR ownership. We are a part of the Tata Group, with Panatone Finvest Ltd. (a subsidiary of Tata Sons Pvt. Ltd.) being the majority shareholder. Tejas has a rich portfolio of patents and has shipped more than 900,000 systems across the globe with an uptime of 99.999%. Our product portfolio encompasses wireless technologies (4G/5G based on 3GPP and O-RAN standards), fiber broadband (GPON/XGS-PON), carrier-grade optical transmission (DWDM/OTN), packet switching and routing (Ethernet, PTN, IP/MPLS) and Direct-to-Mobile and Satellite-IoT communication platforms. Our unified network management suite simplifies network deployments and service implementation across all our products with advanced capabilities for predictive fault detection and resolution. As an R&D-driven company, we recognize that human intelligence is a core asset that drives the organization’s long-term success. Over 60% of our employees are in R&D, we are reshaping telecom networks, one innovation at a time. Why Join Tejas: We are on a journey to connect the world with some of the most innovative products and solutions in the wireless and wireline optical networking domains. Would you like to be part of this journey and do something truly meaningful? Challenge yourself by working in Tejas’ fast-paced, autonomous learning environment and see your output and contributions become a part of live products worldwide. At Tejas, you will have the unique opportunity to work with cutting-edge technologies, alongside some of the industry’s brightest minds. From 5G to DWDM/ OTN, Switching and Routing, we work on technologies and solutions that create a connected society. Our solutions power over 500 networks across 75+ countries worldwide, and we’re constantly pushing boundaries to achieve more. If you thrive on taking ownership, have a passion for learning and enjoy challenging the status quo, we want to hear from you! Who we are: At Tejas Networks, System Engineering team, integral to the PLM organization, plays a crucial role in crafting every successful customer experience. Comprising skilled and committed professionals from various wireline technology domains, the team ensures that customers enjoy a seamless and gratifying journey from pre-sales through to network deployment and beyond. System Engineering division is a close-knit group of network enthusiasts dedicated to designing and implementing robust, maintenance-free networks that stand the test of time. What you work: As a Lead Engineer you will be responsible for driving technical projects, managing resources effectively, balancing team workloads. You will design solutions, oversee testing, and mentor junior engineers to ensure productivity and skill development. Also, you will manage resources, troubleshoot, debug issues, writing and reviewing test cases to ensure code quality, and collaborate with cross-functional teams to deliver high-quality products on time. Handle product demos, customer lab, customer POCs, field POCs, NBI integration activities Prepare customer solution document for deployments Prepare solution document for POCs and demos. Be the Subject Matter Expert on Product capabilities/network solutions. Understands the telecom standards and best practices of the telecom domain. Interact with diverse teams like R&D, Product Management and Sales team to understand the customer requirements Lead a team of 2-3 engineers and drive the activities Mandatory skills: Should be willing to travel domestic and abroad Should be well versed in GPON, OLT, ONT, EMS/NMS and L2/L3 switching Should be familiar with ITU G.984, G.988, TR101, TR156, TR069 standards Should have hands on experience in product testing Should have customer interaction experience Desired skills: Knowledge on TMF REST, OSS, NBI integration is a plus Preferred Qualifications Experience: 7 to 10 yrs from Telecommunication or Networking background. Education: B.Tech/BE (CSE/ECE) or any other equivalent degree Should be well versed in GPON, OLT, ONT, EMS/NMS and L2/L3 switching. Diversity and Inclusion Statement : Tejas Networks is an equal opportunity employer. We celebrate diversity and are committed to creating all inclusive environment for all employees. We welcome applicants of all backgrounds regardless of race color, religion, gender, sexual orientation, age or veteran status. Our goal is to build a workforce that reflects the diverse communities we serve and to ensure every employee feels valued and respected.

3+ years in Spotfire, business analytics or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred. Program reports of various complexity from documented requirements, using Spotfire, Python, SQL.

Roles and Responsibilities Collaborate with cross-functional teams to ensure accurate data analysis and reporting. Conduct literature searches to gather relevant information for medical writing projects. Participate in training sessions to improve knowledge of medical writing best practices.

Job Title: Principal Statistical Programmer Experience: Minimum 12 year of experience as clinical SAS programmer Location: Hyderabad Job Type: Full-Time Professional Summary: The Principal Statistical Programmer is responsible for leading and developing high-quality programming that support sponsors research programs at an expert level. In addition, the Principal Statistical Programmer has an active role in continuous improvement and is expected to act as a leader in the department. Roles and Responsibilities: Follow the department and company standard operating procedures (SOPs), policies, and standards. Provide feedback and update these guidelines as needed. Using SAS, perform SDTM, ADaM, and table, figure, and listing (TFL)programming, quality control (QC) review, and create documentation of programs used in creating statistical outputs. May perform role of Lead Statistical Programmer on studies, portions of studies, or programs. Act as expert in programming and Clinical Data Interchange Standards Consortium (CDISC) deliverables. Understand regulatory agency standards and provide final deliverables in accordance with these standards (i.e., final CDISC deliverables for studies to be included in Food and Drug Administration [FDA] submissions). Collaborate with Lead Biostatisticians and the study team to resolve any study-related questions and ensure that programming outputs represent the statistical analysis plan (SAP) and raw data from external sources and the clinical database. Perform peer review and take accountability for ensuring programming accurately reflects the raw data. Follow current SDTM standards and current ADaM Implementation Guides. Lead studies and/or study-related programming activities. Perform review of the clinical database in regard to visit naming, Clinical Data Acquisition Standards Harmonization (CDASH), and accurate data collection to provide clinical data that is analyzable and meets the needs of the Biostatistics team. Understand timelines and milestones affecting work. Create Biostatistics deliverables that follow the protocol and SAP. Understand and update SAS programs to adapt to various study situations and perform self-review to ensure outputs are as expected. Accurately import external data to be used in TFLs. Reconcile external data and provide findings for non-reconcilable items to the Data Management team. Interact with other staff members to understand and explain SAS programs accurately. Provide technical expertise for internal and external clients and independently bring project solutions to the Biostatistics team and other departments. Analyze existing processes and explore improvement solutions. Develop and lead in intradepartmental or interdepartmental process and quality improvement initiatives. Perform and plan the development, implementation and validation of new process technologies, macros, and applications. Oversee direct reports as assigned. Mentor and train programmers or other team members and/or develop training materials as needed. Other tasks as requested. Educational Qualification: Bachelor's Degree in programming, health-related sciences, or relevant field. Skills: Good to have R programming knowledge and experience. Excellent verbal and written communication skills. Professional attitude and strong interpersonal skills. Ability to work well with a multi-disciplinary team of professionals. Client-focused approach to work. Flexible attitude with respect to work assignments and new learning. Ability to prioritize workload. Superior attention to detail. Understanding of clinical research and the relationship of Data Management in the clinical study process. Proven history of continuous improvement. Successful management or mentoring experience of direct or indirect reports. Strong technical aptitude and ability to adapt to multiple data management platforms. Good computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to multiple information technology (IT) systems Role & responsibilities Preferred candidate profile

About The Role : Job TitleClient Implementation Analyst, NCT LocationPune, India Role Description In accordance with Anti-Money Laundering Requirements, Banks are obliged to perform Know-your-client (KYC) reviews on all new clients they adopt. These checks and reviews are made in strict accordance with regulatory requirement and the banks internal policies. The project involves verification of the Client data, performing due diligence checks on the Clients, reviewing KYC documentation performing the risk assessment of the Client, liaising with the Business/Compliance, advising on KYC requirements and signing off on new client adoptions. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Responsible for verification of Client data Perform due diligence of new and existing clients covering a wide range of different client types including; Listed and Regulated, small/medium/ large private and public companies as well as more complex structures such as; SPVs, Co-operatives, Foundations and Funds, Governments, Joint Ventures, etc. Verifying KYC documentation of the Clients to be adopted/reviewed Perform the risk assessment of the Client to be adopted/reviewed Signing off on new client adoptions and periodic reviews Manage New Client Adoption or Periodic Review stream, to ensure that all requests are approved in accordance with regulatory requirements and the banks internal policies Manage exception ensuring that all SLAs defined with the Business on timeliness and quality are adhered Your skills and experience Domain Skills 1 to 2 years of relevant work experience (AML/KYC/compliance related) within corporate financial services industry, Research/Analytics role in other Banks / KPOs etc Understanding of Control, Compliance, Investigation/chasing functions in banks Familiarity AML/KYC regulations and industry guidelines Ability to interpret regulatory guidelines and assessing risk scores and entity types Ability to interpreting alerts Ability to identifying trends and inconsistencies Understanding of end to end KYC process Communication and Reasoning skills Good German Language Skills Written & Verbal B2.2 level Good reading, comprehension and critical reasoning skills Good analytical writing skills Good communication skills to communicate at all levels - onshore & stakeholders Soft Skills Ability to work independently and take ownership Flexibility while handling multiple cases of varying priorities Graduates with good academic records Exposure to draft procedures based on policies formulated by the Bank's AML Compliance departments. Relevant KYC experience in any Financial Sector for a minimum of 2 years How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm

Position Overview: We are seeking a highly experienced and visionary Medical Director to lead and oversee all medical and clinical initiatives within the organization. This role is pivotal in ensuring the medical and scientific integrity of our programs, providing strategic direction, and driving excellence across research, clinical operations, and stakeholder engagement. The ideal candidate will bring deep clinical expertise, strong leadership capabilities, and a passion for advancing healthcare outcomes through evidence-based practices and innovative solutions. Key Responsibilities: Provide strategic medical leadership across all research, clinical, and operational activities. Oversee the design, execution, and evaluation of clinical trials and research studies. Ensure compliance with all regulatory requirements, ethical standards, and Good Clinical Practice (GCP) guidelines. Serve as the primary medical representative in internal leadership discussions and external engagements with regulators, academic institutions, partners, and key opinion leaders (KOLs). Review, interpret, and communicate clinical and scientific data to support organizational goals and initiatives. Guide the development of medical content including clinical study protocols, scientific publications, regulatory documents, and strategic medical plans. Collaborate closely with cross-functional teams including R&D, Regulatory Affairs, Pharmacovigilance, and Commercial functions to align medical strategy with organizational objectives. Lead and mentor a multidisciplinary team of medical professionals and clinical staff. Support the development of risk management plans, safety monitoring, and adverse event reporting systems. Contribute to strategic planning and organizational growth from a medical perspective. Required Qualifications & Experience: MBBS/MD or equivalent medical degree (Postgraduate specialization in relevant field preferred) Minimum 1015 years of progressive experience in clinical research, medical affairs, or healthcare leadership roles Demonstrated experience in clinical development, regulatory affairs, and medical governance In-depth understanding of medical ethics, patient safety, and quality standards in clinical settings Proven track record of cross-functional leadership and stakeholder engagement Excellent analytical, communication, and decision-making skills Experience in interacting with regulatory authorities and health policy bodies is highly desirable