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5.0 - 7.0 years
3 - 8 Lacs
hyderabad, telangana, india
On-site
Drives implementation of CDGM initiatives, projects and process improvement activities to enhance the planning and execution of migrations to and from enterprise clinical eDMS at Novartis. Act as CDGM point of contact for partnering with CDGM, IT (internal and external) and business stakeholders to plan and execute migrations to and from eDMS, in line with Novartis business, compliance and operational requirements. Partner with CDGM and business stakeholders, especially those planning in-licensing and out-licensing activities to identify and agree migration business requirements, understand source and target system capabilities and develop/maintain a future migration roadmap. Contribute to a...
Posted 2 weeks ago
1.0 - 5.0 years
1 - 20 Lacs
hyderabad, telangana, india
On-site
Description We are seeking a Global HEOR Systematic Literature Review Lead to join our team in India. This role will focus on leading systematic literature reviews to support health economics and outcomes research initiatives on a global scale. Responsibilities Lead systematic literature reviews in health economics and outcomes research (HEOR) for global projects. Develop and implement literature review protocols and methodologies. Collaborate with cross-functional teams to gather relevant data and insights. Analyze and synthesize information from various sources to inform HEOR strategies. Prepare comprehensive reports and presentations for internal and external stakeholders. Stay updated on...
Posted 2 weeks ago
7.0 - 12.0 years
7 - 12 Lacs
hyderabad, telangana, india
On-site
It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us. Prepare and oversee the review and approval of scientific and regulatory submission documents. Serve as functional area lead on product teams. Maintain key business relationships with cross-functional product team members and appropriate management staff across the Amgen R&D organization. Provide expertise and guidance on document design and principles of good medical writing to individual staff, the depart...
Posted 2 weeks ago
6.0 - 11.0 years
6 - 11 Lacs
hyderabad, telangana, india
On-site
Amgen's Clinical Computation Platform Product Team manages a core set of clinical computation solutions that support global clinical development. This team is responsible for building and maintaining systems for clinical data storage, data auditing and security management, analysis and reporting capabilities. These capabilities are pivotal in Amgen's goal to serve patients. The Principal IS Architect will define the architecture vision, create roadmaps and support the design and implementation of advanced computational platforms to support clinical development, ensuring that IT strategies align with business goals. The Principal IS Architect will work closely with partners across departments...
Posted 2 weeks ago
2.0 - 6.0 years
0 Lacs
rourkela
On-site
The job requires a Graduate degree level qualification and is a Full-time position located at ISPAT Post Graduate Institute and Super Specialty Hospital in Rourkela, Odisha, 769005, IN. Please apply before 04/30/2025, 11:23 AM.,
Posted 2 weeks ago
5.0 - 9.0 years
0 Lacs
maharashtra
On-site
As a Claims Manager at Unifeeder Group of Companies, your primary responsibility will be to receive claims intimations from various member entities within the organization. You will be tasked with collecting and consolidating claim details, information, and documents, in order to prepare Statement of facts, risk analysis, and report the claim to the Insurer. Your role will also involve claim tracking, data consolidation, reporting, and accurate record management. Additionally, you will be responsible for liaising with member entities, external experts, lawyers, surveyors, and insurers to analyze claims, mitigate risks, and reduce costs. You will actively participate in the risk management an...
Posted 2 weeks ago
3.0 - 7.0 years
4 - 9 Lacs
hyderabad
Work from Office
We are seeking an experienced and detail-oriented Medical Reviewer to join our team. The role involves reviewing, analyzing, and ensuring accuracy, consistency, and compliance of medical and scientific content in alignment with regulatory, clinical, and organizational standards. Key Responsibilities Review medical, clinical, and regulatory documents for scientific accuracy, clarity, grammar, and compliance. Ensure consistency of terminology, data, and style across all documents. Validate clinical and safety data in reports and submissions against source documents. Collaborate with cross-functional teams including medical writers, clinical research, and regulatory affairs. Provide feedback an...
Posted 2 weeks ago
3.0 - 6.0 years
7 - 11 Lacs
kolkata, mumbai, new delhi
Work from Office
The primary function of the Workforce Management Analyst will be to aid the Associate Director, Workforce Management and Insights with managing the Workforce Management platform and using Analytical tools to generate reporting within the Contact Center. Essential Functions: Support in providing strategic leadership by sharing responsibility for overseeing the optimization of the organizations workforce including managing staffing levels, forecasting labor needs, scheduling employees efficiently, analyzing workforce data, and implementing strategies to maximize productivity and align staffing with business objectives. Collaborate with various departments to ensure efficient resource allocatio...
Posted 2 weeks ago
3.0 - 7.0 years
11 - 14 Lacs
kolkata, mumbai, new delhi
Work from Office
We are seeking a strategic and detail-oriented Senior Proposal Writer to join our high-performing Proposals, Budgets, and Contracts team. In this role, you will lead the development of compelling, client-focused proposals that showcase Novotech s capabilities and drive business growth. You ll collaborate with cross-functional teams and engage directly with clients to deliver tailored solutions that win work and build lasting partnerships. Key Responsibilities Lead the creation of customized proposals in response to RFPs, RFIs, and client requests. Strategize proposal content to align with client needs and Novotech s service offerings. Collaborate with clinical, operational, financial, and bu...
Posted 2 weeks ago
3.0 - 7.0 years
9 - 12 Lacs
kolkata, mumbai, new delhi
Work from Office
We are seeking a strategic and detail-oriented Senior Proposal Writer to join our high-performing Proposals, Budgets, and Contracts team. In this role, you will lead the development of compelling, client-focused proposals that showcase Novotech s capabilities and drive business growth. You ll collaborate with cross-functional teams and engage directly with clients to deliver tailored solutions that win work and build lasting partnerships. Key Responsibilities Lead the creation of customized proposals in response to RFPs, RFIs, and client requests. Strategize proposal content to align with client needs and Novotech s service offerings. Collaborate with clinical, operational, financial, and bu...
Posted 2 weeks ago
0.0 - 1.0 years
0 Lacs
hyderabad
Remote
Key Responsibilities Programming & Data Handling Write SAS programs to manage, transform, and analyze clinical trial data. SDTM Development Map raw data into SDTM domains following CDISC standards. ADaM Dataset Creation – Develop analysis-ready datasets for statistical analysis and regulatory reporting. TLF Generation – Produce Tables, Listings, and Figures (TLFs) for clinical study reports and FDA/EMA submissions. Validation & QC – Perform independent programming checks to ensure accuracy and compliance. Documentation – Maintain specifications, programming logs, and compliance documents for audits Raw Data Mapping – Extract, clean, and map raw clinical data from multiple sources (EDC, lab, ...
Posted 2 weeks ago
3.0 - 7.0 years
5 - 9 Lacs
hyderabad
Work from Office
We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs & trainings Job Summary: As Scrum Master, you are responsible for developing a high performing, self-managed dynamic team minimizing impediments to deve...
Posted 2 weeks ago
4.0 - 9.0 years
6 - 11 Lacs
pune
Work from Office
Job Description THE POSITION: At EVERSANA, our integrated life sciences compliance team is taking a leading role in helping some of the most scientifically advanced Biopharma and research companies around the world to innovate novel therapies for rare, ultra-rare and a range of critical therapeutic areas including Oncology, Neurology, Immuno-oncology, Immunology etc. This role is within the EVERSANA Compliance team reporting directly to the Manager, Medical Content Development. This person will also collaborate very closely with other team members with in the EVERSANA Compliance Business Unit (Medical Information, Medical Affairs, Pharmacovigilance, Regulatory and Quality). The position will...
Posted 2 weeks ago
2.0 - 5.0 years
4 - 8 Lacs
gurugram
Work from Office
International Solar Alliance is looking for REGULATORY SPECIALIST to join our dynamic team and embark on a rewarding career journey Diagnosing and treating illnesses, medical conditions, and injuries. Ordering, performing, and interpreting diagnostic tests. Collecting, recording, and maintaining patients' information and histories. Prescribing and administering treatments, therapies, medications, vaccinations, and other specialized medical care. Explaining procedures and discussing test results or prescribed treatments with patients and family members. Monitoring patients' conditions and progress. Directing, coordinating, consulting with, and referring patients to nurses, students, assistant...
Posted 2 weeks ago
2.0 - 5.0 years
7 - 11 Lacs
gurugram
Work from Office
International Solar Alliance is looking for Finance Audit Specialist to join our dynamic team and embark on a rewarding career journey Diagnosing and treating illnesses, medical conditions, and injuries. Ordering, performing, and interpreting diagnostic tests. Collecting, recording, and maintaining patients' information and histories. Prescribing and administering treatments, therapies, medications, vaccinations, and other specialized medical care. Explaining procedures and discussing test results or prescribed treatments with patients and family members. Monitoring patients' conditions and progress. Directing, coordinating, consulting with, and referring patients to nurses, students, assist...
Posted 2 weeks ago
9.0 - 15.0 years
35 - 45 Lacs
hyderabad
Work from Office
We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs & trainings Job Summary: As Scrum Master, you are responsible for developing a high performing, self-managed dynamic team minimizing impediments to deve...
Posted 2 weeks ago
4.0 - 9.0 years
20 - 25 Lacs
bengaluru
Work from Office
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Conduct Monitoring Visit Report Reviews (MVRRs) Collate output from multiple data sources and conduct site risk assessments Identify sites to be selected for MVRRs based on a predefined set of risk criteria Prepare documentation for MVRR review Review a sampling of Moni...
Posted 2 weeks ago
5.0 - 8.0 years
3 - 8 Lacs
bengaluru
Work from Office
Test, debug and potentially automate ETL processes using PL/SQL and Json. Support the production deliverables and investigating production issues. Communicate with immediate supervisor and other project team members on the status of work-in-progress, both verbal and written communication Work very closely on production database/environment Update project, system, and other technical documents, as required Work in any of the shifts as demand by project
Posted 2 weeks ago
5.0 - 10.0 years
12 - 14 Lacs
chennai, bengaluru
Work from Office
Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner May perform data entry for paper-CRF studies, as needed May perform quality control of data entry May provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed. Assist in developing CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation. May oversee overall quality of the clini...
Posted 2 weeks ago
3.0 - 8.0 years
5 - 10 Lacs
pune
Work from Office
Provide experienced technical expertise to develop process methodology for department to meet internal and external clients needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. Essential Functions Perform, plan and co-ordinate the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing summaries and (ii) the pro...
Posted 2 weeks ago
6.0 - 11.0 years
6 - 10 Lacs
thane
Work from Office
Minimum 6+ years experience with ADaM and TFL programming , Experience in Oncology studies on Efficacy ADaMs and TFLs (ADTTE PFS, OS, DOR, BOR, ORR is must) Experience on KM Plots, waterfall plot, Forest plot is required
Posted 2 weeks ago
2.0 - 7.0 years
5 - 8 Lacs
bengaluru
Work from Office
Accountable for the training, performance management, and mentoring of assigned Project Managers Provides ongoing coaching and feedback to Project Managers, including addressing performance issues, conducting formal performance appraisals, and creating development plans Escalates performance issues to Senior Director Project Delivery & Transformation Coordinates Project Team Meetings, including the development of meeting agendas and minutes Ensures training occurs and evaluates proficiency or additional training needs of Project Management (PM) staff Tracks PM utilization with the goal to ensure at least 90% utilization of all staff Motivates and develops the team Develops and oversees recru...
Posted 2 weeks ago
0.0 - 1.0 years
1 - 5 Lacs
kolkata
Work from Office
Serve in support level capacity in CDM Validation (Testing) team, to perform testing activities in CDMS environment to provide efficient, quality database as per customer requirement. Essential Functions Conduct testing activities to validate Edit Checks, SAS listings, Transfer programming and custom reports in platforms like InForm, RAVE, OCRDC and/or Oracle Clinical. Basic understand database structures. Understand the documentation requirements and update all relevant documents in a timely manner. Understand and comply with Standard Operating Procedures and Work Instructions (including Best Practice and Guidance documents). Meet project objectives as assigned by the Validation Team Lead o...
Posted 2 weeks ago
1.0 - 6.0 years
1 - 4 Lacs
noida
Work from Office
Key Responsibilities: Liaising with doctors, nurses, and other healthcare professionals to ensure the safe, effective, and economical delivery of drug treatments. Participating in dispensary work, including clinical checks and accuracy checking of prescriptions and dispensed medicines. Ensuring all work complies with Medicines Ethics and Practice, local policies and procedures, risk management, and health and safety protocols. Dispensing and supplying medicines. Receiving, storing, and supplying controlled drugs in accordance with hospital policy. Creating purchase orders (P.O.) and preparing GRNs for the same. Processing purchase returns of medicines due to expiry. Handling narcotics and ma...
Posted 2 weeks ago
5.0 - 10.0 years
5 - 15 Lacs
mumbai
Work from Office
SUMMARY SAR & SAR-like Patient Safety Physician Job Description Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborating with Therapeutic Head to identify signals and address product safety concerns Engaging with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensuring 100% compliance with timely completion of all client and Cognizant required trainings Achieving 100% compliance with work allocation plan, including case clos...
Posted 2 weeks ago
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