234 Clinical Operations Jobs - Page 8

Responsibilities: * Doctors Engagement * Oversee clinical operations & data management * Manage medical services team performance * Drive quality improvement initiatives * Ensure compliance with regulatory standards Health insurance Provident fund

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Associate Qualifications: BE/BTech/Masters in actuarial science Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be part of our Life Sciences R&D division, which offers a comprehensive range of services across the life sciences sector. This includes Clinical Data Management, regulatory services, pharmacovigilance, and patient services solutions. Employees within this clinical capability will join one of our sub-offerings, such as Clinical Database build and Clinical Reporting. In these roles, you will support leading biopharma companies in realizing their vision, enhancing outcomes by focusing on the patient and integrating scientific expertise with unique insights into the patient experience.The Clinical Database Management team is committed to developing and maintaining databases for clinical trials, which includes creating Case Report Forms (CRFs) and developing Edit and Validation Checks using programming skills like C# and PL/SQL. They also support data integration from various external sources such as labs and Interactive Response Technology (IRT). The team ensures compliance with regulatory standards and guidelines, maintaining high levels of data quality and security. Additionally, they continuously seek to improve database processes and tools by leveraging the latest technologies and best practices to enhance efficiency and accuracyThe Clinical Reports Programming team is dedicated to developing and maintaining clinical reports for clinical trials. This involves utilizing PL/SQL, SQL, and Clinical SAS programming skills to create these reports. The team also integrates data from various sources such as EDC, Labs, and IRT. Ensuring that all reports comply with regulatory standards and guidelines is a crucial part of their work. They implement stringent quality assurance processes to uphold the highest levels of data integrity and report accuracy. Additionally, the team collaborates closely with clinical operations, biostatistics, and other departments to ensure the reports meet the needs of all stakeholders, facilitating informed decision-making based on accurate and timely data. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningCandidates who have completed B.Tech or B.E in Computer science in 2024 & 2025 (if all semester s results are available) Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BE,BTech,Masters in actuarial science

Deva Institute of Healthcare and Research Pvt Ltd is looking for Clinical Research Coordinator to join our dynamic team and embark on a rewarding career journey. Coordinate and manage clinical trials from initiation to completion, ensuring compliance with regulatory guidelines and study protocols Recruit, screen, and enroll study participants while maintaining accurate documentation and records Monitor patient safety, manage informed consent, and schedule follow-ups Communicate with investigators, sponsors, and regulatory authorities to ensure timely updates and reporting Maintain study supplies, track data collection, and support data analysis, ensuring high-quality and ethical research practices throughout the study

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional All Job Posting Locations: Bangalore, Karnataka, India, Delhi, Delhi, India, Hyderabad, Andhra Pradesh, India, Kolkata, West Bengal, India, Mumbai, India Job Description: Global Clinical Operations (GCO) Senior Site Contract Manager, Global Site Contracting (CCS) *: (*Title may vary based on Region or Country requirements) Position Summary: Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team in the pricing, planning, execution and control of grants and contracts. Principal Responsibilities: Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations. Responsible for delivery on established targets/measurements. Responsible for analyzing contract requests/needs from operating companies and translating into appropriate contracts/budgets for company sponsored and investigator initiated clinical trial agreements and other relevant legal documents as they relate to various clinical projects. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies. Provide specialized support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required. Analyze investigator grants for fair market value aligned with regional knowledge and the J&J grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information. Participate in and/or lead the approval escalation of grants as appropriate. Work with the global CCS team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions and communicate such to stakeholders. Liaise with CCS management and functional CCS support teams, legal, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate. Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites. Mentor and train new contract coordinators and analysts. Assume responsibility for all aspects of legal document and metrics tracking. Determine potential needs for contract amendments and manage amendment lifecycle. Exemplary customer focus with vision to drive solutions This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned. Principal Relationships: This position reports to Manager, Site Contracting Internal: Internal Business Partners (CCS, TA, MAF, MAO, GD, HCC, Risk Management, Legal, etc.) outside parties External: Clinical Investigator Sites Commercial Suppliers Clinical Research Organizations (when applicable). Education and Experience Requirements: Bachelor s degree in appropriate scientific or business disciplines 3 to 5 years-experience and/or equivalent competencies in pharmaceutical industry/clinical research Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) a plus Must have a working knowledge of the clinical development process with two (2) years of negotiation and contract experience Familiarity with clinical research processes Ability to work effectively in cross function teams Strong and proven negotiation and problem resolution skills Working knowledge of PCs (MS Office suite at a minimum) and database management Must demonstrate innovative spirit, have strong interpersonal skills, and ability to manage a high volume of work Previous experience working in virtual teams preferred. DECISION-MAKING AND PROBLEM-SOLVING: Adhere to SOPs, ethics and departmental compliance as determined by GD management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with CCS, GD and operating companies. Comply with requests from QA and auditors. Able to work independently as well as in a collaborative team environment. Other: Fluency in English required. Travel Percentage: 10%

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. The role may require you to identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The role may also need expertise in managing clinical data management projects. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy

Senior hospital administrator who oversees both the administrative and medical aspects of a hospital, ensuring its smooth operation and delivery of high-quality patient care. Responsible for all Medical administrative work. Required Candidate profile supervise clinical departments and Medical staff, ensuring quality of care and patient safety. Identify areas for improvement in hospital operations and implement changes to enhance patient.

The responsibilities include developing and managing the framework for Clinical process, service quality and customer experience for all service lines under Surgery care & Dental. This role will ensure end to end process streamlining and enhancements via QA and QC measures across functions to ensure best quality of care, customer experience, business growth and scalability. This role is critical in ensuring the highest standards of patient care through clinical audits, prescription validation, call monitoring, and effective coordination with various healthcare stakeholders (Ops, Customer support, Inside Sales, Product & Tech, Marketing, Sales & AM, Finance) to improve the entire customer experience and drive process improvements. Key Roles & Responsibilities: Ensuring all the Clinical calls are happening as per the SOP Conduct regular audits of clinical calls to ensure adherence to medical protocols and guidelines. Identify areas for improvement and provide structured feedback for quality enhancement. All concerns were addressed through timely follow-ups with the network, CST, Insurance MB, hospital SPOCs, medical teams, ICU doctors, and senior surgeons. Develop and implement Standard Operating Procedures (SOPs) for handling missed inbound calls. Leverage prescription verification insights to improve the Surgery suggested funnel and better conversion Monitor and contribute to reducing the number of missed calls by the team. Lead, manage and monitor the entire CSAT framework to ensure CSAT, DSAT and NPS process flow Explore and introduce channels and mechanisms to capture customer feedback and surveys to increase the response rate and CSAT coverage Ensure identification of the process gaps and timely CAPA to enable continuous process improvement Identify the need for Quality improvement projects (QIP) as a part of RCA analysis to ensure continuous service quality improvement Lead, manage and monitor daily ticket flow, closure and zero pendency for surgery care and dental tickets on freshdesk Identify the complaint trends, common issue patterns and areas of improvement across all stages and overall processes. Skills & Requirements: Must have 7-8 years of experience, including expertise in Clinical and QA (hospital-related) processes, as well as Customer Experience in the healthcare sector. Experience in audits (Clinical/Non Clinical), prescription validation, and healthcare coordination is preferred. Strong communication, problem-solving, and team management skills Ability to work in a fast-paced environment and coordinate with multiple stakeholders. Knowledge of medical documentation and compliance standards Good analytical skills - working with large, complex datasets and deriving insights and identifying gaps and areas of improvement Ability to take constructive criticism and take corrective action - being open to feedback and closing the feedback loop Tool requirements - Advanced proficiency in Excel, Powerpoint, basic knowledge of additional analytical, Quality and CRM tools.

Hi, We are hiring for Leading ITES Company for Medical Writer Profile. Role & Responsibilities: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57

Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & Responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error-free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of training Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training new team members as and when required. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 205 b) To Apply for above Job Role ( Pune ) Type : Job Code # 206 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 207

Assistant Lab Director Gurgaon Full-Time Job Description The Assistant Laboratory Director is responsible for the overall operation and administration of the laboratory services throughout the project locations. His/her primary responsibility includes planning, organizing and directing the overall operation of the Laboratory Department. Job Activities includes performance of chemical, microscopic and bacteriologic tests performed in the laboratory to obtain data for use in diagnosis and treatment of diseases. Ensure that services are of the best quality, are cost contained and are carried out in an expeditious manner. Additional responsibilities include recognizing results or problems that require referral to the Pathologist, assuring competency of all personnel, formulating the budget for the department, maintaining performance improvement activities within the department and running quality improvement programs and maintaining efficient and effective departmental operations in compliance with all state, federal, and local regulatory laws, standards and protocols in the respective countries including licensing, permit etc. 1. Participates in the recruitment and selection process for Lab employees. 2. Performs clinical supervision of employees, including regular performance appraisals and feedback to staff. 3. Provides supervision of clinical scheduling, call and leave for medical employees. 4. Provides supervision of continuing professional education, in-service training and orientation of new medical staff. 5. Ensures integration of medical services into companys overall comprehensive services. 6. Actively participate in purchase of lab equipment; and other services. 7. Leads planning for the development of new clinical programs. 8. Provides counsel in personnel matters relating to the clinical staff. 9. Performs or delegates responsibility for quarterly medical record reviews for all medical staff focusing on quality of care and appropriate coding. Administrative Functions: 1. Work with central team on planning, organizing and directing laboratory operations and ensuring compliance with all local, state and federal regulations. 2. Responsible for the fiscal operation of the department 3. Development and constant review of Standard Operating Procedures of various lab functions across locations. 4. Keeps abreast of the healthcare and medical regulations and advises management team on necessary changes. 5. Provides clinical guidance and regularly reports on clinical activities to the management. 6. Reviews necessary clinical and patient care contracts for services provided to or by the organization 7. Performs periodic review of practice management functions. 8. Serves as a liaison between lab services and administration. 9. Represents the organization at local medical societies, hospitals, professional organizations, groups and agencies as and when required. 10. Participates, in conjunction with the management team, in the overall budgetplanning and monitoring process; reviews the formulation and evaluation of project goals and budgets. Essential Functions: 1. Review and judge effectiveness of LAB operation, utilization of employees and supplies, and general ethical and professional atmosphere is maintained. 2. Oversee work schedules for lab. Technicians on a daily basis to ensure proper coverage. 3.Oversee Organizing the leaves and vacations to ensure an enduring lab coverage. 4.Direct location lab supervisors to ensure proper guidance to lab technicians in their daily tasks and monitoring their performance on a regular basis. 5.Annual personnel performance evaluation ,Validating the daily quality control

Who we are We re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What the Clinical Operations Department does at Worldwide Clinical Research Associates (CRAs) play a vital role in ensuring our clinical research programs are executed with the quality and excellence our sponsors expect and the care and passion patients deserve. These roles are the backbone of every strong CRO, helping drive breakthrough scientific research and playing a lead role on every clinical trial. All CROs will promise you growth, opportunity and maybe even a challenge. But we offer more than that. We offer an uncommon experience - one you can t get anywhere else, with a team unlike anyone else. At Worldwide we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every trial like a patient s life depends on it - because it does. Our leaders are in the trenches with you daily - committed to advancing science and moving mountains for our customers. What you will do Responsible for managing the research activities at sites participating in Worldwide s clinical research projects, which are predominantly registries and other types of non-interventional / observational studies Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the sites activities during study maintenance, and closing down research activities at the sites once the study has c oncluded Conduct study initiation visits (SIVs) While most of the site management efforts will be performed remotely, will be required to ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirement What you will bring to the role Excellent interpersonal, oral, and written communication skills in English Superior organizational skills with attention to details Ability to work with little or no supervision Proficiency in Microsoft Office, CTMS and EDC Systems Your experience 5+ years of experience as a Clinical Research Associate Demonstrable experience of handling multiple protocols across a range of therapeutic indications Four-year college curriculum in life sciences, OR Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) Ability to meet the travel requirements of the job We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at Discover a world of difference at Worldwide ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn . Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law .

1. To examine all patients on admission in ICU/ ER/ other such Clinical area as designated by Clinical Administration from time to time. 2. To order investigations under guidance of the departmental Head/ Coordinator 3. To write and fillup all documents and patients history sheet and MLC and other such forms as ordered by Clinical Administration from time to time. 4. To seek Consultation and do referrals to Specialist and Consultants from time to time as per Clinical protocol and hospital policies. 5. Must be well versed with medical knowledge and practice, able to perform bed side procedure like Catheterization, intubation, central line insertion (in case of emergency) 6. To take and give written handover at the bedside at the beginning and end of the duty shift. 7. To rectify or correct any clerical other such errors committed by the retainer here in agrees tovisit the hospital at the earliest irrespective of the next schedule of the duty shift. 8. To document all administrative related policies and other such documents of similar nature as guided by the clinical Coordinator and general administration from time to time. 9. To train nurses, paramedical and support staffs while on duty and as ordered by the clinical admin from time to time. Qualification- BAMS, BHMS, MBBS

Role & responsibilities Patient Recruitment and Screening: Identifying and screening eligible patients for clinical trials, ensuring they meet the study criteria. Informed Consent: Obtaining informed consent from participants, explaining the study's purpose, procedures, and potential risks. Data Collection and Documentation : Accurately collecting and documenting study data, including patient information, vital signs, and other relevant information. Protocol Adherence: Ensuring the study follows the established protocol, regulations, and ethical guidelines. Participant Monitoring: Continuously monitoring participant safety and well-being, reporting any adverse events. Communication and Coordination: Communicating with participants, investigators, and other team members to ensure effective collaboration. Administrative Tasks: Managing study budgets, supplies, and records. Preferred candidate profile Graduation - B. Pharm Post-Graduation - M. Pharm Pharm D

As a Senior Clinical Trial Transparency Associate you will be joining the worlds largest & most comprehensive clinical research organisation, powered by healthcare intelligence, You will oversee and execute the clinical transparency (i-e, registration, updates and/or results disclosure) or public disclosure processes for assigned studies and/or assets conducted by client globally, What You Will Be Doing Manage the creation and maintenance of clinical transparency or public disclosure process documents while ensuring adherence to all applicable laws, regulations, industry guidance and corporate position, Monitor and interpret global regulatory requirements and the industry environment affecting clinical transparency or public disclosure and communicate changes to the fellow team members, partner departments and department stakeholders, Assess requirements for clinical trial registration / disclosure of results or public disclosure strategy plans, Make appropriate decisions regarding the applicability and timing of clinical transparency or public disclosure activities according to national laws, regulations, industry guidance and corporate position, Manage the review and approval process for clinical trial registrations, registration updates, results disclosures or public disclosure strategy plans or public disclosure tracking mechanisms, including communication with partner companies or collaborators, Facilitate periodic review of active registrations or public disclosure strategy plans to ensure records are updated or verified as required, Provides feedback to Clinical Transparency or Public Disclosure leadership resulting from new and updated transparency requirements 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, 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,com/benefits https://careers iconplc , com / 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,

Job Responsibilities Lead and manage a research team in order to curate accurate, timely, insightful and comprehensive data and intelligence; Identify and analyze the most relevant information for Beacon and its users; Coordinate with UK based clients on a regular basis to understand and meet the project deliverables. Manage the activities required towards launch of a beacon module and further support the needs towards maintenance post launch. You will be part of a global network of life science researchers working on dynamic, fast growing products in exciting, cutting edge life science areas. Perform data management activities on the assigned project in a timely and efficient manner Generate queries to clarify and improve the quality of the data Strong understanding of Clinical Trials and their data Strong understanding on preclinical data What attributes will you need? An ideal candidate might be a subject matter expertise in various drug therapies in field of oncology (Antibody drug conjugate/Bispecific/Adoptive cell therapy/Checkpoint modulators/oncolytic virus/Gene therapy) and experience with managing a team of resources Proven ability to deal with complex life science concepts Excellent written and verbal communication skills. Previous experience in a research role and/or data-oriented role is desirable but not essential. Experience and understanding in the field of pharmacology, drug discovery and development and clinical trials would be a bonus. Good project and people management skills are a must have. Results-oriented, passionate about delivering value and impact, proactive Most of all, you will need to be curious and willing to learn at all times. Eligibility: Masters in Pharmacy (except Pharmacognosy)/Biology/Bio-Technology/Bio-Chemistry/Pharm D with minimum 2-3+ years of relevant experience Bachelors in Pharmacy (except Pharmacognosy)/Biology/Bio-Technology/Bio-Chemistry with at-least 4 years of relevant experience Candidates with additional Clinical research diploma or relevant courses can apply. Candidate should have basic computer skills, Microsoft Office & detailed Internet Knowledge. Candidate should have one research paper published Ability to work in a high-pressure, deadline-driven environment Exceptional communication and reporting skills

Role & responsibilities MIS and Reporting: Maintain and update the Clinical Management Information System (MIS). Generate and circulate daily, weekly, and monthly operational reports to internal stakeholders. Ensure data accuracy and timely reporting. Coordination with Doctors: Liaise and coordinate with doctors and clinical partners across India for scheduling, documentation, and operational requirements. Act as a point of contact for communication between internal teams and external medical professionals. Payment & Invoice Processing: Handle the end-to-end process for clinical invoice validation and payment processing. Maintain payment trackers and coordinate with the finance team for timely disbursements. KOL Coordination: Support the planning and execution of KOL-related initiatives including meetings, events, and collaborations. Maintain an updated database of KOLs and ensure effective engagement. Licensing & Compliance: Oversee the renewal and documentation of all clinical licenses. Ensure 100% compliance with PCPNDT regulations and maintain proper records. Stakeholder Communication: Prepare and share daily operational updates with leadership and cross-functional teams. Address queries and provide operational insights as needed. Qualifications: Bachelors degree in Healthcare Administration, Life Sciences, Business Administration, or a related field (Masters degree is a plus). 2–5 years of experience in clinical operations or healthcare administration. Familiarity with clinical compliance frameworks, especially PCPNDT. Strong knowledge of Excel and MIS tools; proficiency in data handling and reporting. Excellent communication, coordination, and interpersonal skills. Ability to multitask and manage stakeholders across geographies. Key Competencies: High attention to detail and data accuracy Stakeholder management Time and process management Problem-solving and adaptability Compliance and documentation proficiency

Should have Strong Knowledge in medical review of ICSRs and Pharmacovigilance Knowledge of safety databases, such as Argus, ARISg. Familiarity with medical coding dictionaries (e.g., MedDRA) and adverse event reporting standards (e.g., ICH E2B). Required Candidate profile Conduct thorough and objective medical review of ICSRs received from various sources, including clinical trials, spontaneous reports, and literature. BDS and MBBS Are eligible to apply

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 Minimum Bachelor's or Masters degree in related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Are Applicable to Apply

Role & responsibilities: Ensures that qualified by education, training, and experience to assume responsibility for the proper conduct of the clinical studies. Maintaining current, up-to-date curriculum vitae . Assuming responsibility for the conduct of the clinical investigation. Signing the protocol Documenting the financial aspects of the trial. Disclosing conflicts of interest as described in the regulations. Ensuring adequate number of qualified staff and adequate facilities for conductance of the study properly and safely. Ensures that all persons assisting with the study are adequately informed about the protocol, the investigational product(s), and their study-related duties and functions. Ensuring that medical care is provided to a subject for any adverse event(s) that is reported. Informing a subject when medical care is needed to treat an inter-current illness. Provide information regarding adverse events and serious adverse events to the IRB/IEC. Possessing a thorough understanding of the requirements of each protocol . Ensuring recruitment goals are reasonable and attainable. Assessing overall protocol feasibility. Following the trials randomization procedures. Ensuring that the informed consent form contains the entire Essential and additional elements required. Conduct of the clinical studies specified by the applicable regulatory requirement(s), the IRB/IEC requirements and/or the regulatory authorities. Conduct the study as per the principles of ethics and is compliance with Good Clinical Practices (GCP). Attending education workshops. Reviewing professional publications. Participating in professional societies Maintaining a list of qualified persons and their corresponding trial-related delegated duties. Preferred candidate profile can send to email: hr@qpsbioserve.com or raghavendra.kundhula@qpsbioserve.com Perks and benefits: Nil

Roles and Responsibilities Clinical Pharmacy Manager with a demonstrated history of working in the hospital & health care industry. Skilled in Pharmacy operations, JCI & NABH accreditations, Pharmacovigilance, Healthcare Management, Medicine, Clinical Pharmacy, Policy Management and Adverse Event Reporting. Strong healthcare services professional with a Master of Pharmacy (M. Pharma), focused in Hospital Pharmacy (Operations & Clinical) Supervise pharmacy operations, ensuring accurate dispensing of medications and adherence to pharmaceutical regulations. Oversee pharmacy staff, including pharmacists and technicians, providing guidance and training. Ensure compliance with local & state pharmacy laws and regulations. Manage medication inventory, procurement, and storage to prevent shortages or wastage. Implement policies for safe medication handling, storage, and disposal. Provide consultation to patients regarding prescriptions, dosage, and potential side effects. Collaborate with healthcare professionals to optimize medication therapy management. Monitor financial performance, budgeting, and cost control measures for the pharmacy. Preferred candidate profile Bachelor's or Master's degree in Pharmacy/ Healthcare Administration Proven experience in clinic and pharmacy management. Strong leadership and organizational skills. Excellent communication and interpersonal abilities. Knowledge of healthcare regulations, insurance policies, and pharmaceutical guidelines. Ability to handle administrative tasks, including budgeting, staffing, and performance evaluations. Interested candidates can their resume to Career@group-108.com

Key Responsibilities: Daily Operations Management Client Experience Team Coordination Sales & Targets Oversight Inventory & Asset Monitoring Reporting & Communication

RoleClinical & Therapy Development Manager Type Full Time Job description - Successfully complete our internal training plan to include hemodynamics, ECG, angiography, echo CT imaging modalities and complete the case support and proctor delegate authorizations. - Provide active commercial case support, demonstrating excellence in procedural success rates patient outcomes. - Scrub in sterile and provide TAVI valve loading in procedures training instruction to trial and commercial customers - Provide our customers CT valve sizing analysis utilizing the Pie Medical 3Mensio CT program - Lead customer didactic education sessions for account activation before first implants - Lead pre case planning debriefing of heart team pre post procedure and provide ongoing education as requested for proper in - service levels - Provide documentation as required for quality assurance initiatives - Co-develop commercial business plan for assigned region - Co-support internal/external quarterly business reviews - Data entry into Salesforce, Mentor software for customer case support management - Learn commercial data analytics, resources tools for effective customer experience - Support customer engagement strategy with Marketing team (TM)) - Demonstrate competency with marketing messaging, clinical evidence and medical education portfolio offering - Demonstrate knowledge in the TAVI market, industry competitive insights - Participate in team meetings, conventions, and national sales meetings as requested - Drive innovative marketing and referral activities in collaboration with the markeitng team - Collaborate with the Sales and marketing team to conduct targeted market development in India Sub-continent. - Lead organization and delivery of key symposia by supporting discussions with customers to define agenda topics, select appropriate speakers / chairs, create required materials for events. - Develop Key Opinion Leaders within this segment to create market for the new therapies which will be launched and create advocates for your product who will speak on various forums - Identify high potential international / national referral community meetings to target for market development and collaborates with sales management team to put forward case for investment (program contributions / symposiums / workshops) This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Handling front Office

Fresher Hiring 2023 - 2025 Passouts only - All India Qualification - B.Pharm, M.Pharm, B.SC, M.SC, Life Sciences Graduates & Post Graduates Medical - BDS, BHMS, BAMS, MBBS Role & responsibilities Perform data reconciliation between different data sources and study documents to ensure data integrity and consistency across datasets. Generate data queries to address discrepancies, inconsistencies, and missing data identified during data review, ensuring timely resolution and documentation of data queries Communicate data queries to investigative sites, data managers, and study personnel, following up on query responses and resolving discrepancies in collaboration with relevant stakeholders Identify deviations from protocol-specified procedures, eligibility criteria, and data collection guidelines, escalating issues to appropriate personnel for resolution Perform quality checks and data validation procedures to ensure accuracy, consistency, and reliability of clinical trial data, adhering to data management standards and industry best practices Assist in the development and implementation of data validation plans, data review guidelines, and quality control procedures to maintain high standards of data quality and integrity. Assist in a variety of specialties including but not limited to primary care, orthopedics, rheumatology, etc. Updates patient history, physical exam, and other pertinent health information in the document as required. Complies with Compliance standards of the Organization as laid by HIPAA. Performs other duties and tasks to improve provider productivity and workflow as assigned by supervisors. Assist documenting the patients, electronic health record (EHR). Fresher Hiring - Pharma / Life Sciences / Medical Qualification - B.Pharm, M.Pharm, B.SC, M.SC, Life Sciences Graduates & Post Graduates Medical - BDS, BHMS, BAMS, MBBS Location - All India - Delhi, Mumbai, Pune, Bangalore, Kochi, Chennai, Hyderabad, Ahmedabad, Bhopal, Indore, Kolkata, Chandigarh

Summary -To plan and lead Category initiatives for a clearly defined sub-category globally OR one category regionally OR all categories in one country OR multiple cross-divisional categories in one country; to develop the sub-category strategy as part of the wider Category Strategy; to lead proactive sourcing projects, specification definition and demand management, as we'll as manage sub-category-specific supplier performance and innovation activities. About the Role Position Title: Global Category Manager, Clinical RD Location : Hyd-india #LI Hybrid Job Purpose: The Global Category Manager, responsible to manage Clinical functional services Categories in space of Data Management, Statistical Programming, Trial Monitoring, Regulatory, Pharmacovigilance Medical Writing, plans and leads all strategic Procurement activities within the assigned categories, at a global level and develops proposals for strategic sourcing decisions. The role provides high value procurement solutions to the business and category strategies; supports third party vendor selection, vendor development, technology management and supplier performance measurement activities. The Global Procurement Category Manager ensures best-in-class delivery of external services in support of functions and to realize year-on-year productivity improvements, cost savings, and process improvements working in close collaboration with Business Stakeholders. Your responsibilities include but not limited to: The role is responsible for all Novartis Global spend for assigned Global Clinical Operations functions . These services have FSP long term engagements with goals for value creation and continuous improvement. Specifically, you will be responsible to develop sourcing strategies for clinical study delivery supporting Novartis development pipeline. Establish strategic category plans tailored to assigned categories/sub-categories, in congruence with organizational objectives. Lead the sourcing, negotiation and contracting to leverage buying power and recommend appropriate Procurement strategies and tactics to obtain desired results Support/Lead the design and implementation of executive governance around preferred suppliers the objective of which is to ensure performance delivery, continuous improvement, and access to innovation from supplier arrangements to achieve value contribution targets on a global basis Negotiate complex Commercial Terms and masterservices Agreements working collaboratively with Business Stakeholders, Legal, Data Privacy and Supplier Quality Accountable for a proportion of the overall Clinical category savings target and leads proactive category projects, spanning sourcing projects, demand management and process improvement, as we'll as managing sub-category specific supplier performance and innovation activities to support the delivery of the global procurement targets. Provide financial and business analysis (eg Data mining of supplier spend from Procurement and Financial Systems, output analysis and interpretation), supporting global market intelligence in the category area and acting as the focal point for category subject matter expertise to the global business and procurement community. Support in the indirect management of Clinical Sourcing Managers by assisting in their quarterly and year end reviews, provide support in establishing their goals within the category and assist in their development. Essential Requirements: Successful project execution by providing all external solutions in time / at the required quality / within budget as verified by the business. Value Delivery - optimized Total Cost of Ownership and cost productivity/savings in compliance with approved Novartis Finance Productivity guideline. Successful and measurable execution on efficiency programs Measurable and continuous process improvement compliance assurance. Understanding the Procurement KPIs related to market insights, price and demand development as we'll as procurements performance. Compliance with all GxP relevant processes Strong project management and/or other leadership experience. Knowledge of Global RD Clinical CRO market What you'll bring to the role: masters Degree/other advanced degree in Lifesciences or Pharmaceutical sciences MBA degree is preferred A minimum of 12 years Core experience in strategic negotiations, alliances, and operations in RD at a pharmaceutical company or a contract research organization. Emphasis on business, experience with clinical processes and activities and associated ESP services, with excellent understanding of study management and overall integration of clinical data system and processes