1999 Clinical Trials Jobs - Page 12

The Clinical Pharmacist is responsible for ensuring the safe, and cost-efficient use of medications in patient care. Ensure compliance with hospital policies, federal regulations, and accreditation standards NABH.Improvement, and clinical audits.

Position - Area Manager - Payments - Merchant Acquiring/Senior Area Manager - Payments - Merchant Acquiring Culture Anchor:Work Hard - Consistently puts in effort. plans and tracks daily progress to achieve targetsExecute with Rigor - Takes responsibility for meeting targets with focus and effortOwn It - Maintains honesty and fairness in all interactions in line with organizations policiesAct with Integrity Duties and Responsibilities FOS Management:- Recruit, train and motivate the team- Manage the FOS productivity Distribution development:-Acquire merchant - Drive QR deployment, SB deployment and POS/EDC Deployment -Build distribution for the business (business development).-Initiating and...

-Responsible for all statistical programming/data review reporting and analytics development aspects of several studies, a medium to large sized project or project-level activities. Acts as a key collaborator and strategic partner in ensuring that drug-development plans are executed efficiently with timely and high quality deliverables. Complies with project / study standards and specifications following internal and regulatory guidelines. Oversees programming style, quality of statistical reporting & compliance with timelines. About the Role Major accountabilities: Lead statistical programming activities for several studies or drive the implementation of data analytics reports -Make decisio...

This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical t...

As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. Our values We believe in applying scientific rigor to reveal the full promise inherent in data. We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. We prize innovation and seek intelligent solutions using leading-edge technology. Here at Cyte...

Responsibilities: * Collaborate with cross-functional teams on study start-up, monitoring & closeout * Manage clinical trials from planning to completion * Ensure compliance with regulatory requirements

Contributes as unit representative on project teams. Ensures that own deliverables are met. Interprets results, evaluates data, draws conclusions and reports back to team and management -Coordinates internal and external stakeholders, customers and/or vendors and performs stakeholder management -Proactively drive project execution to ensure key milestones and quality are met -Act as unit representative on development teams and/or other cross functional teams -Communicates issues involved stakeholders and to teams and line management and propose corrective actions -For GMP units: ensure compliance to cGMP -Organizes and ensures regular lessons learned sessions -Coaching and technical training...

Co-ordinate activities of data managers either internally or externally. Make data management decisions and propose strategies at project or disease level. May act as a local manager of global associates including providing supervision and advise to these data managers on functional expertise and processes Build and maintain effective working relationship with cross-functional teams incl. Trial Management, Trial Monitoring and Statistical Reporting counterparts, able to summarize and discuss status of deliverables and critical Data Management aspects impacting outcomes. Comply with company, department and industry standards (e.g. CDISC) and processes, ensuring data management innovations and...

Provide subject matter expertise to support digital endpoint deployment across clinical, scientific, and technology domains Provide digital health technology SME knowledge to support the qualification and onboarding of third-party digital health technology providers for clinical trials Manage vendor selection, oversight, and execution across all phases of trial start up, conduct and close out Drive operational integration of digital endpoints within Novartis processes and global clinical operations Monitor patient recruitment and device compliance, escalating risks and resolving issues as needed Support data management and data operations in database setup, data standards, transfer, cleaning...

Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements. Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products. Partner with the CMC RA Sci...

At Bristol Myers Squibb, we re creating innovative medicines for patients who are fighting serious diseases. We re also nurturing our own team with inspiring work and challenging career options. No matter our role, each of us makes a contribution. And that makes all the difference. We are seeking an experienced and dynamic Senior Manager to lead our Record-to-Report (R2R) team within the Finance Controllership function. This role requires a qualified Chartered Accountant with a minimum of 8 years of post-qualification experience and a strong track record in driving process efficiencies, automation, and standardization within financial reporting. The ideal candidate will oversee a team of app...

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. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of c...

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. JOB DETAILS Provide technical leadership for process development of downstream unit operations for purification of monoclonal antibodies (mAbs) with unit operations ranging from clarification, chromatography, TFF and formulation. To strengthen the c...

About The Role Credit Card Process Manager Marketing HO Department Credit Card Products Location Infiniti IT park Reporting Relationship Position Grade Senior Manager Job Role Process designing for Credit Cards covering key aspects of Process Workflows (Digital / Physical), Compliance, Risk, Legal, Ops, Customer Experience, etc. Creating and documenting SOPs/Process notes of various Credit Card processes with clear defined roles and responsibilities to promote efficient implementation. Ability to think through end to end process at various touchpoints such as online channels, partners, Branches, Call center etc. Review processes in light of Fraud and Risk raised by RCU and ORM. Identificatio...

Analyses, reviews, and interprets safety data, both non-clinical and clinical, literature and any other relevant sources Responsible for performing end to end case processing of Individual case safety reports to meet regulatory timelines Perform initial evaluation of spontaneously reported adverse events including reports from post marketing surveillance studies Responsible for identifying duplicate/invalid ICSRs Perform case processing from clinical trial, literature, spontaneous, market research, social media and solicited cases for both serious and non-serious reports Perform data entry for all subject information into EDC databases as required Perform peer review, quality review of cases...

Pharmacovigilance (PV) Quality Assurance System Governance. Maintaining oversight of the quality systems within Pharmacovigilance department. Review &/or Approval of Quality system documents related to Pharmacovigilance. Ensure compliance with written procedures/policy/manuals. Ensure all time readiness of Pharmacovigilance function for client audits/visits and regulatory inspections. Handling of External Audits, Regulatory Inspections, & client visits related to Pharmacovigilance function. Monitor the deficiencies and deviations within PVD and shall ensure compliance and implementation of Corrective and Preventive Actions (CAPA) in accordance with relevant QMS SOP. On-boarding & training of...

Review of the world wide scientific and medical literature in accordance with companies-controlled documents. Maintain organized records of all literature safety reports received and reported. Basic entry of MLM cases received from the authority by uploading and importing XML and RTF files and by analysing received source document. Perform duplicate check. Manage tracking of MLM cases with source of receipt. Ensuring compliance with local regulations and companys global pharmacovigilance requirement. Weekly reconciliation of MLM cases with source of receipt. Deliver training to new joined and team as per requirement. Case processing including data entry, drug coding, MedDRA coding, assessmen...

Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR for submission to local and other Health Authorities. Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities. Authoring of Signal Management Reports. Performing literature search and validity check for the aggregate reports. Reconciliation of relevant process trackers. Extraction and validation of data (RSI, Sales, previous reports, RMP, signals). Generation of Line Listings (LL) from safety database Providing reliable support for high priority Ad-hoc activities. Ensure all the reports are drafted within the allocated timelines.

Job Descriptions : Job Title: Ass. Manager Clinical Research & IPR Job Location: - Plot No. 214, Borsad - Tarapur Road, Ta: Petlad, Dist: Anand, Gujarat, India. Department: R&D / Regulatory Affairs Experience: 7 to 10 years in nutraceuticals, clinical research, and IPR. Industry: Nutraceutical / Food / Pharma Manufacturing Reports To: Head of R&D / Director Job Type: Full-Time Company Profile: - Pharmanza Herbal Pvt. Ltd. is one of the few companies which is focusing on standardizing and proving the efficacy of Herbal products. Our strong supplier base, fully equipped R&D facility, FDA approved manufacturing facility, infrastructure for conducting human trials as well as our formulations uni...

Major accountabilities: Team Leadership: Lead a team to ensure alignment with organizational goals and business priorities related to Migration activities, and support the strategic vision for Platform Operations from a Capability level;foster a culture of excellence and continuous improvement Act as a Change Lead and implement change management strategies to ensure smooth adoption of technology initiatives, at the Capability level Roadmap Development: Responsible for the oversight, the planning and the continuous execution of migration activities across Technology Projects/Products, and their alignment as part of an integrated roadmap, from a Capability level Coordinate with relevant affect...

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 an...

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 creating/programming complex SAS edit checks according to specifications, testing them for functionality and identify potential issues before implementation. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement po...

As an MCH Onco Surgeon at our facility in Dwarka, New Delhi, you will play a vital role in providing specialized surgical care to oncology patients. Your primary responsibility will be to deliver high-quality, evidence-based surgical interventions to effectively treat cancer patients and enhance their quality of life. Working as a key member of our oncology team, you will significantly contribute to the multidisciplinary approach in managing cancer cases and provide essential expertise in surgical interventions. Your key responsibilities will include performing complex oncological surgeries with precision and attention to detail. You will collaborate closely with multidisciplinary teams to d...

As a DM Cardiologist, you will be responsible for conducting thorough assessments of patients with cardiovascular issues and diagnosing cardiac conditions using advanced imaging and diagnostic tools. You will create individualized treatment plans based on patient needs and perform interventional cardiology procedures as required. Managing chronic conditions through ongoing patient monitoring and collaborating with other healthcare professionals to optimize patient care will be key aspects of your role. Additionally, you will be expected to educate patients and their families about cardiovascular health, participate in clinical trials and research projects, and stay current with advancements ...

Premier Research is seeking an Associate Director, TMF Process, Systems, and Training to join the Pharmacovigilance and Records Management team. In this role, you will play a pivotal part in assisting biotech, medtech, and specialty pharma companies in translating groundbreaking ideas and scientific advancements into new treatments. Your work will directly impact saving and enhancing lives, highlighting the invaluable contribution of our team members towards achieving success. As an essential member of our team, you will be instrumental in driving the improvement of TMF processes, systems, and training within Global Records Management (GRM). Collaborating with Departmental Leadership, you wi...