20 Clinical Monitoring Jobs

• Respond to queries/ clarifications from EC/ IRBs and on sites • Attend drug safety/external meetings/investigator meetings • Patient eligibility review • Review AE/ SAEs • Protocol training of site staff, CRAs etc

Premier Research is looking for a Clinical Trial Associate II to join our Global Clinical Monitoring and Site Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech . Join us and build your future here. Document Management Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) in collaboration with the clinical team as defined by the organizations or Sponsor s SOPs and all applicable regulatory requirements. Creates and maintain placeholders in the TMF based on TMF filing plans, expired documents, study milestones, site staff changes, and other applicable events. Reviews site documents and verifies they meet or exceed all company, sponsor, regulatory authority, and ALCOAC standards. Performs Quality Review and completeness checks of relevant eTMF sections in compliance with company or Sponsor processes throughout start up, maintenance, and close out activities and ensures follow up with clinical team of resolution of findings. Conducts follow up with the internal team on TMF queries to ensure timely resolution. Routinely runs and distributes eTMF reports to clinical team to facilitate quality and compliance. May assist SSUAs/CRAs with essential document collection and review during startup, maintenance and close out. May support the translation of site documents or reviews translations of site documents, if required. Data entry, Tracking, Reporting and System Support Assists the clinical team with CTMS set up and data entry into project tracking systems, as applicable, including but not limited to site contact updates, site address updates, maintain site assignments and site activation activities, e.g. vendor activities. Assists the clinical study team in the tracking and documentation of Investigators Brochure and safety report distribution as well as other documents/materials sent to sites, e.g. newsletters. Assists with managing and tracking access to systems, (i.e. CTMS, Vendors, EDC, IWRS, etc.) for site staff and clinical team; including conduct of routine reviews, to ensure access removal. Reviews the project specific training matrices and reports to ensure compliance of clinical team. May create CRA workflows to manage site follow up items. Other Attends internal clinical meetings as required and assist with meeting preparation and follow up (decisions, actions, issue logs). Supports the CRA/clinical team in liaising with third party vendors to solve and follow-up on issues e.g. on study equipment, translations. Supports other study specific tracking, such as Q&A log. Participates in available internal training offered to increase therapeutic knowledge. Assists the clinical team with the development of study material, such as create Investigator/Pharmacy site files in collaboration with the study team before Site Initiation Visit; includes working with vendor for creation and distribution of ISF Binders (upload documents, review proofs, trigger shipments). Coordinates general office logistical activities as requested May mentor and train less experienced CTAs May be a point of contact for IT issue resolutions Identifies, manages, escalates issues where appropriate and collaborates with Project Team and Line Manager to identify solutions. May participate in departmental initiatives. Performs additional duties and assignments as required.

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

At Allucent , we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Clinical Research Associate Contractor (Sr.CRA) to join our A-team (remote). As a Sr. CRA at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice. In this role your key tasks will include: Governs highest possible quality standards for trial monitoring activities. Conducts all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours. Monitors activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines: Performs efficient site management in line with study budget. Prepares and submits quality Site Visits Reports and Contact reports. Maintains and updates CTMS in compliance with SOPs and study-specific directives. Acts as Document Owner for collected documents. Conducts co-monitoring as needed. Provides functional assistance to the project team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation (CTMS, TMF). Liaises with project team members and Sponsor to track study progress and milestones. Tracks and supervises collection of ongoing study data for purpose of regular project status reporting within agreed timelines. May review essential documents (GLP) as a 2nd line or Independent Reviewer (IR). May participate in organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA training. May perform assessment visits. Represents Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personnel. Identifies potential logistical/practical problems and propose solutions / contingency plans, with timeframes for resolution. Acts as the lead contact in case several CRAs involved for a same study in same country. Supervises generation of electronic tracking systems and logs to produce status updates, progress reports and general management of the clinical deliverables when needed. May process and track payments to the Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators and /or vendors including timely notification to finance department, as applicable. May participate in meetings with clients. May support project manager/CTL and project functional leads in the project oversight and management. Supports site staff in preparation for study related site audits and inspections. Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions. To be successful you will possess: At least five years clinical monitoring experience and/or relevant clinical trial experience. Relevant life science degree / medical / nursing background, or combina

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.

Job description Remote & Full-time Opportunity for professionals with direct experience of min 2 years in disclosures. Job Description Summary The Clinical Trials Disclosure Specialist II position is responsible for the overall coordination and development of multiple disclosures deliverables, including but not limited to compliant registry authoring and maintenance of information on public registries, document redaction, and/or plain language authoring, ensuring adherence to relevant industry guidelines and client styles and formatting in accordance with all agreed upon timelines. Job Description Essential Functions: Independently performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (i.e., Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable). Ensures development of high-quality registry, redaction, and plain language document deliverables that are compliant with all applicable policies, procedures, and regulations. Performs independent quality control review of registry and/or plain language document deliverables, ensuring accuracy against all relevant source documents. Works closely with internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Clients disclosure obligations. Works with internal Client team(s) to ensure the source information is provided for disclosure activities in a timely manner. Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking. Sets expectations where necessary and reports on project statuses to manager. Escalates issues to manager in a timely manner. Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time. Maintains constructive and positive interactions with colleagues. Develops strong, lasting relationships with client teams that encourage organic new business growth. Other duties as assigned. Necessary Skills and Abilities: Strong written and verbal communication skills. Self-motivated and able to work independently. Exceptional time management skills. Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries. A proven team player who can focus on and drive goal completion. Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency Works independently with good time management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency.

Key Responsibilities 1. Clinical Oversight Ensure adherence to treatment protocols and SOPs across all units. Monitor clinical indicators, patient outcomes, and audit reports. Guide units on medico-legal processes, compliance, and NABH standards. Review critical incident reports and follow up on action taken. Provide clinical direction during health emergencies or outbreaks. 2. Administrative Coordination Supervise hospital operations remotely through MIS, dashboards, and unit-level coordination. Support policy implementation and resolve escalated clinical-operational issues. Standardize workflows across departments in consultation with Unit Heads. Facilitate inter-unit coordination to maintain continuity of care. Monitor implementation of hospital-wide initiatives and strategic plans. 3. Consultant Recruitment & Review Lead the recruitment and credentialing of Consultant Doctors across Secure units. Periodically review consultant performance and clinical alignment with hospital standards. Coordinate with HR and unit heads for manpower planning and onboarding. Ensure compliance with credentialing, licensing, and renewal protocols. Advise on distribution of specialties based on patient demand and hospital goals. 4. Resource & Budget Oversight Review department budgets, resource utilization, and staffing data. Advise on cost-effective service delivery and equipment use. Support finance teams with clinical input on billing justifications and service coding. Recommend clinical resource optimization across multiple units. Track utilization trends and suggest corrective actions as required. 5. Compliance & Stakeholder Liaison Ensure legal, ethical, and clinical compliance through remote monitoring. Coordinate with regulatory bodies and represent hospital in external audits or legal matters as needed. Oversee medico-legal documentation and court-related submissions. Maintain liaison with empanelment bodies, insurers, and public health officials. Review compliance reports and initiate policy-level improvements when needed. 6. Strategic & Clinical Advisory Support new clinical programs, specialty launches, and service upgrades. Analyze patient feedback and recommend service improvements. Guide digital health initiatives and clinical innovation efforts across units. Identify emerging healthcare trends for long-term planning. Collaborate with leadership on enhancing Secure Hospitals clinical reputation. Strong Experience in Hospital Leadership or Medical administration. Note : Prospective candidate should be open for travelling to all the Units as part of the job as and when it is necessary. Min 7 to 10 days of Travelling in the 1st 6 months. After 6 months one can plan the Travelling Schedule according to the Requirement. Qualifications MBBS Hospital Admin qualification preferred 10+ years in hospital leadership or medical administration Strong remote coordination, compliance, and strategic planning skills Key Skills and Competencies: Strong leadership and decision-making abilities. Excellent communication and interpersonal skills In-depth knowledge of hospital management systems and clinical protocols. Ability to handle crises and manage conflicts. Familiarity with healthcare regulations and accreditation standards.

>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

The Medical Monitor will serve as the primary medical expert responsible for the safety and scientific integrity of clinical trials. This role provides medical oversight to ensure patient safety, proper conduct of trials

• Respond to queries/ clarifications from EC/ IRBs and on sites • Attend drug safety/external meetings/investigator meetings • Patient eligibility review • Review AE/ SAEs • Protocol training of site staff, CRAs etc

Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e. g. , Trial Master File (TMF)) that track site compliance and performance within project timelines. Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for completeness. Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training. May collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Qualifications High School Diploma or equivalent Req 3-4 years administrative support experience. r Equivalent combination of education, training and experience. Minimum one year clinical research experience strongly preferred. Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint. Written and verbal communication skills including good command of English language. Effective time management and organizational skills. Ability to establish and maintain effective working relationships with coworkers, managers, and clients. Basic knowledge of applicable clinical research regulatory requirement, i. e. , Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training. Knowledge of applicable protocol requirements as provided in company training. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs. iqvia. com

Urgent Hiring for NO-1 IT MNC for Medical Monitor ( SR Manager ) Location - Mumbai Salary Up-to - 30 LPA ONLY MBBS / MD with 3 + Yrs exp required In Clinical Trial Operations ,Review AE/SAEs protocols etc. Call @ WhatsApp- Vishakha - 8287990567

The job responsibilities include two roles Project Standards Manager (PSM) will manage the activities associated with the consistent implementation of global clinical data standards for BMS projects and studies Global Standards Manager (GSM) will assist in the leadership of the development and maintenance of BMS s global clinical data standards and related supportive processes Each individual can perform PSM, GSM or a combination of the two roles. Development, maintenance and Implementation of BMS clinical data Standards Participate in the development and maintenance of global clinical data standards, including operational (CRF and non-CRF) CDISC Study Data Tabulation Model (SDTM), controlled terminology, non-CRF standard data mappings (e.g., lab or ECG), and other applicable industry standards. This could include creation of the metadata and mappings between the standards (operational and SDTM), and documentation of the use of the standard. Participate in relevant study team meetings as standards SME and provide input for standards components, such as CRF design, CRF Completion Guidelines, Programmed edit checks, Data transfer specifications, SDTM mapping specifications and SDTM annotated CRF. Act as an expert on operational data standards, SDTM and/or Analysis Data Model (ADaM) standards, and Clinical Data Interchange Standards Consortium (CDISC) controlled terminology. Act as a consulting resource for study teams regarding the validation of SDTM domains, which may include output from industry standard software tools and BMS custom validation programs. Work with standards management systems and software, such as Metadata Repository, Change Request systems, SDTM validation systems, and issues tracking systems, in the development of systems and processes for creation and maintenance of data standards, including specifications, mappings between standards, and checking adherence to these data standards. Coach CROs and vendors on BMS data standards and related processes Communicate and reinforce content and interpretation of BMS data standards to project and study teams, to ensure consistency in understanding and implementation of standards across a project. Standards Governance Organization and submissions support Process clinical data change requests for new or existing metadata, including developing a Standards manager recommendation and implementation plan for the standard, as applicable, and ensuring that the request is processed through the appropriate levels of the CDSGO Participate in the committees of the CDSGO, partner with functional area stewards, organizing standards topics to be reviewed and ensuring decisions are made in a timely manner, documented in meeting minutes and other forms, and implemented. Provide input and information to facilitate key discussions and decisions regarding standards use and implementation. Provide guidance to Study Teams and Submission Teams on SDTM standards and related submission requirements, (e.g., SDTM annotated CRF, define.xml/pdf, Reviewer s Guide, XPT files). Participate in Study / Submission team meetings, as applicable. Other Key Activities Participate in the development of CDSI or cross functional SOPs, Working Procedures, Guidance documents, and job aids. Participate in the identification, review, evaluation, and implementation of new technologies related to data standards. Develop training materials and provide training on CDS-developed processes. May coach more junior personnel or contract staff, as required Participate in strategic initiatives, special projects, and working groups contributing to business decisions and process changes Identify and propose process improvements while maintaining a strategic focus. Share new industry standards, best practices with project and study teams, and within department as required. Degree Requirements Bachelor s degree required Experience Requirements At least 7 years of relevant industry experience with clinical trials, preferably with clinical data standards as a focus. Experience in Industry Standards (e.g. CDISC) in either the collection (CDASH), tabulation (SDTM) or analysis (ADaM) models. Experience with Medidata Rave(EDC) and Metadata Repository (MDR) is preferred. Experience interpreting Health Authority regulations with a strong compliance background. Strong working knowledge of the overall pharmaceutical development process. Strong working knowledge of SDTM and the creation of data mapping specifications and annotated CRFs. Knowledge of requirements of define.xml. Experience in CRF design, query resolution, and general data validation. Good communication skills, high ability to communicate standards related issues, options, and their impact to project teams and within department. Ability to work effectively in a team environment with medical personnel, study managers, project managers, clinical monitors, data managers, programmers, and statisticians

Role & responsibilities Study start-up: Site feasibility assessment, Site evaluation/selection, Site / Investigator financial & study contract execution, Prepare EC submission packages. Site management & clinical study monitoring : Site initiation & liaison Ing, Site staff training / re-training, Oversee sites on patient recruitment, Patient retention etc., Site recruitment issue/trouble-shooting, Study monitoring, Source data verification/ensure \ data quality, Support site audits, Site close out Management of clinical trial supplies Vendor management Project management : Tracking timelines & budget, Site & vendor invoice payments, Coordinate with cross functional teams Preferred candidate profile M.Sc / M. Pharma with relevant CRA experience of 2-7 Years Interested Candidates can share their CVs on vilshashah@torrentpharma.com

Job Description: Clinical Research Manager Position Overview The Clinical Research Manager (CRM) in a specialty pharmaceutical company plays a pivotal role in the design, execution, and management of clinical studies (BE/BA/TE) focused on innovative and specialized therapies. This position requires a strong background in pharmacokinetics, pharmacology, and clinical research, with a keen understanding of the unique requirements of specialty pharma products. The CRM will oversee end-to-end clinical research activities to ensure timely, compliant, and successful study outcomes. Key Responsibilities 1. Clinical Study Design and Execution Lead the design, planning, and implementation of clinical studies, particularly in areas requiring pharmacokinetic and pharmacology expertise. Monitor and report the studies at CRO Develop study protocols, investigator brochures, and other study-related documents in collaboration with cross-functional teams. Manage timelines, budgets, and resources to ensure project deliverables are met within scope. 2. Specialty Pharma Expertise Apply pharmacokinetics and pharmacology knowledge to optimize study designs for niche or complex therapeutic areas. Support bioavailability, bioequivalence, and drug interaction studies to meet regulatory requirements for specialty pharma products. Collaborate with formulation and regulatory teams to align clinical studies with product development goals. 3. Regulatory and Compliance Oversight Ensure compliance with global regulatory standards (FDA, EMA, ICH-GCP) and local regulatory requirements. Manage interactions with regulatory agencies, IRBs, and ethics committees. 4. Team Leadership and Project Management Lead and mentor clinical research associates, coordinators, and other team members involved in clinical studies. Timely execution of projects Manager vendors, including CROs, labs, and other service providers, ensuring high-quality deliverables. Foster collaboration among internal and external stakeholders to support study objectives. 5. Data Management and Analysis Collaborate with data management teams to ensure accurate collection and analysis of clinical studies data. Review and interpret clinical data, particularly pharmacokinetic and pharmacodynamic results, to assess drug safety and efficacy. Provide scientific insights to inform regulatory filings, publications, and strategic decisions. Qualifications Educational Background: Advanced degree (Masters, PharmD, or PhD) in Pharmacokinetics, Pharmacology, or a related field. Experience: 5-8 years of clinical research experience, preferably in specialty pharma, with at least 2 years in a leadership role. Demonstrated expertise in pharmacokinetics, including modelling, simulation, and interpretation of PK/PD data. Experience in managing early-phase clinical studies, bioequivalence studies, or rare disease programs. Technical Skills: Strong knowledge of pharmacokinetic principles, drug metabolism, and specialty pharma therapeutic areas. Proficiency in clinical trial software (e.g., Medidata, Trial Master File systems) and pharmacokinetic tools (e.g., NONMEM, WinNonlin). Familiarity with regulatory submission processes for specialty pharmaceuticals. Soft Skills: Excellent leadership, project management, and problem-solving skills. Strong communication skills for collaborating with cross-functional teams and presenting complex scientific data. Detail-oriented and adaptable to the dynamic nature of specialty pharma development. Preferred Qualifications Certification in Clinical Research (e.g., SOCRA, ACRP). Experience in rare diseases, oncology, or other specialty therapeutic areas. Track record of regulatory interaction and successful trial submissions in specialty pharma. Work Environment and Benefits Work in a highly collaborative, innovative, and fast-paced environment. Competitive compensation and benefits package, including health insurance, performance bonuses, and professional development support. Opportunities to contribute to groundbreaking treatments in niche therapeutic areas.

Role & responsibilities Associate Research Physician in clinical trial related projects covers various therapeutic areas, medical review, assessment, and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation and in accordance with applicable regulatory and SOP requirements. Support in the preparation and review of protocol related appendices like Investigators Brochure, Informed Consent Document, Investigators Undertaking, and any other documents related to protocol and CSR. Review of the MedDRA and WHO Drug Insight coding as and when required for the projects. Support the Senior Research Physician in generating SAE narratives and performing quality review and analysis of similar events. Communication of the SAE to all stakeholders as per the format and timelines indicated in the guidelines and internal SOP and keep a track of the same when required for clinical trials. Take a lead role in drafting the Integrated Summary of Safety and Efficacy for all clinical trial projects where in he/she is designated the responsibility. Review of protocol and protocol synopsis for BA/BE and phase studies in collaboration with clinicians, bioanalytical personnel, biostatisticians, regulatory affairs personnel, and medical monitor. Preparation of Medical Monitoring Plan (MMP) and Risk Evaluation and Mitigation Strategy (REMS), if applicable. Preparation of SFQs (Site Feasibility Questionnaires) and summary for patient-based studies. Training the required study team members and addressing protocol related queries in a timely manner. Provide input regarding deliverables with accuracy timelines and processes and support completion of quality regulatory documents. Managing documents with multiple review cycles and deadlines

Opportunities available for both remote and Work from Office (Navi Mumbai) Multiple openings at various levels Experience range: 3 to 15 years of experience Role & responsibilities Explores new prospective sites and conducting feasibility survey for the studies. Have adequate sites selected for each study Assists CPMs in studying start-up activities, regulatory process and execution of study related agreements. Successful initiation of a study Prepares visit reports as per SOPs after each site visit. Releasing site visit reports within the SOP defined timelines Maintains ongoing communication with sites to provide information, queries resolution, and review overall progress of clinical trials and adherence to established guidelines. Ensure sites get adequate support while recruiting patients and conducting studies. Keeps the CPMs updated with the study status at sites. Ensures the correct storage, handling and use of investigational product in accordance with SOPs. Ensure that the IP is stored, used and handled in compliance to SOP. Supervises the CTA in maintaining and updating trial master files on regular basis; Responsible for ensuring compliance to GCP, applicable SOPs and applicable regulatory requirements. Ensure that the study files are maintained adequately by the CTA Performs other study related tasks as assigned by Clinical Project managers. Ensures all tasks assigned by the CPM are completed in time Preferred candidate profile Education: B. Pharm, M. Pharm, B.Sc, M.Sc, Advanced Diploma in Clinical Research Operations Experience: 5 to 12 years Knowledge and Skills: Thorough understanding and experience in complete gamut of activities in Clinical Operations including ICH, GCP and various regulatory requirements. Should have 3 years of on-site monitoring experience, specifically in phase 2 and 3 of trials. Should be willing to travel 15 to 18 days in a month

We are seeking a highly motivated and compassionate recent graduate to join our clinical team as an Entry-Level Clinical Assistant/Clinical Associate. This is an excellent opportunity to gain hands-on experience in a clinical setting and contribute to patient care or clinical research. You will work closely with physicians, nurses, and other clinical staff, assisting with various tasks related to patient care, data collection, and administrative support. This role is ideal for individuals with a strong interest in healthcare and a desire to learn and grow in a dynamic environment. Responsibilities: Patient Care Support: Assist with patient intake and vital sign measurements. Prepare examination rooms and ensure they are clean and stocked with supplies. Provide basic patient support and comfort. Assist with the administration of basic medical procedures under supervision. Clinical Data Management: Accurately collect and record patient data in electronic health records (EHR) or clinical research databases. Assist in the preparation of clinical reports and data summaries. Maintain accurate and organized clinical records. Ensure data integrity and confidentiality. Administrative Support: Schedule patient appointments and manage patient flow. Answer phone calls and respond to patient inquiries. Assist with filing, photocopying, and other administrative tasks. Maintain inventory of clinical supplies. Clinical Research Support (if applicable): Assist with the recruitment and screening of clinical trial participants. Assist in the administration of study procedures and data collection. Maintain study documentation and regulatory files. Ensure adherence to study protocols and ethical guidelines. General Support: Assist clinical staff as needed. Participate in team meetings and training sessions. Maintain a clean and organized work environment. Any other duties as assigned. Qualifications: Bachelor's degree in a Life Science, Healthcare, or related field (e.g., Biology, Nursing, Psychology, Public Health). Strong interest in patient care or clinical research. Excellent communication and interpersonal skills. Strong attention to detail and accuracy. Ability to work independently and as part of a team. Strong organizational and time-management skills. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Must be a recent graduate.

Monitoring and caring for patients in clinics. Investigating, diagnosing and treating the health conditions of patients. Prescribing and reviewing patients medication. Taking accurate notes, as a legal record and for other healthcare professionals to use. To increase the footfall and educating people about their health. Teaching and supervising trainee doctors. Manage a team or department and organize workloads. Research and review processes. Day-to-day working, Administration related work. Any other work related to your dept. Revenue / ROI generation from available resources and achieve company goal and given target. Giving training to sales team Proof reading, content writing Arrangement of Medical Campaigns Telephonic consultation Home visit in case on emergency

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. JOB RESPONSIBILITIES Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): o Assesses site processes o Conducts Source Document Review of appropriate site source documents and medical records o Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines o Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture o Verifies site compliance with electronic data capture requirements May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. Understands project scope, budgets, and timelines for own and others activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned. May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager. For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. Additional responsibilities include: o Site support throughout the study lifecycle from site identification through close out o Knowledge of local requirements for real world late phase study designs o Chart abstraction activities and data collection o As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff o Identify and communicate out of scope activities to Lead CRA/Project Manager o Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations o Identify operational efficiencies and process improvements o Develop country level informed consent forms o Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared o Participate in bid defense meetings Qualifications QUALIFICATION REQUIREMENTS Bachelor s degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected. Ability to manage required travel of up to 75% on a regular basis