Clinical Trials Jobs

Key Responsibilities:1. Ensure compliance with medical devices regulations: As a biomedical trainee, you will be responsible for ensuring that all medical devices and equipment meet the necessary regulatory standards and guidelines.2. Assist in conducting clinical trials: You will support the team in planning and executing clinical trials to evaluate the effectiveness and safety of new medical devices.3. Manage CE certifications: You will help in obtaining and maintaining CE certifications for medical devices, ensuring they meet European regulatory requirements.4. Support FDA submissions: Assist in preparing and submitting documentation to the FDA for approval of new medical devices or modifications to existing ones.5. Assist in patent applications: Help in researching, drafting, and filing patent applications to protect the intellectual property of new medical devices.6. Assist in ISO certifications: Support in obtaining and maintaining ISO certifications for quality management systems related to medical devices.7. Assist in devices calibration: Help in calibrating medical devices to ensure accurate and reliable performance.Required Skills and Expectations:- Post Graduate Diploma or M.Sc in Biomedical Engineering or related field.- Knowledge of medical devices compliances and regulations.- Strong attention to detail and ability to follow strict protocols.- Familiarity with CE certifications, FDA regulations, patent processes, ISO standards, and devices calibration.- Excellent communication and teamwork skills.- Ability to work under supervision and learn quickly in a fast-paced environment.

Review medical records and translate them into standardized codes using ICD-10, CPT, and HCPCS coding systems. Collaborate with healthcare providers to obtain accurate information for coding purposes. Ensure all codes are compliant with healthcare regulations and insurance requirements. Assist in maintaining accurate documentation and coding practices to meet healthcare standards. Communicate with the coding and billing departments to resolve discrepancies or issues. Stay updated with changes in medical coding practices and healthcare regulations. Educational Background: Nursing degree (RN, LPN, or related nursing qualifications). Certification (Preferred, but not required): Certification in Medical Coding (e.g., CPC, CCS) or willingness to pursue certification after employment. Technical Skills: Basic knowledge of medical terminology, anatomy.Why Join Us? Training & Development: Comprehensive Medical Coding training will be provided to help you gain expertise in medical coding. Career Growth: We offer opportunities for career advancement and professional development within the healthcare industry. Work-Life Balance: Flexible working hours and a supportive environment. Competitive Compensation & Benefits: Health insurance, paid time off, and other benefitsQualificationsPharmacy : B.Pharmacy / M.Pharmacy / Pharmd Life Sciences : Microbiology,Biotechnology Biochemistry Botany zoology chemistry BioInformatics Medical : MBBS BDSParamedical : BHMS BAMS GNM ANM Nursing MLT Food and Nutrition

1. Completing all planned customer visits on time and to the levels outlined in application manual.2. Work closely with the sales team to develop and optimize product attributes to achieve maximum customer preference in targeted segments, providing technical support.3. Perform post-sale demos to the customers to develop product understanding and applications knowledge.4. Occasional training of clinical staff on designated equipment. Help customers to understand all the functions of the products and make the best use it.5. Help customers and distributors to solve UIS product issues, response in time.6. Collect distributors and end-users feedbacks; summarize and analyze customer requirements for future product development and upgrade.7. Train the distributors team for better product demo to end users.8. Provide suggestions for the development of distributors application team.9. Keep good relationship with local opinion leaders.10. Support doctors in Clinical Research11. Product Research and new product evaluation12. Have a deep understanding of the key accounts which include good development and maintenance of customer relationship.13. Performing clinical applications 14. Supporting marketing activities15. Conduct product evaluation and share feedback/suggestions with Product Team

Are you a dynamic, results-oriented professional passionate about sales, marketing, and advancing global health solutions? MusB Research LLC, a leader in microbiome, aging, and health-related translational research, is seeking a Sales and Marketing Manager to drive our expansion and growth.Key Responsibilities: Lead Generation: Identify and develop new business opportunities in biotechnology, pharmaceutical, nutraceuticals, and clinical research sectors. Lead Management: Engage and follow up on leads, schedule meetings with our scientific teams, and convert opportunities into project contracts. Client Relationship Management: Serve as the primary point of contact for clients, ensuring smooth communication and satisfaction throughout the project lifecycle, from onboarding to final delivery of results and reports. Collaboration: Work closely with the MusB Research leadership team to facilitate national and international meetings, site visits, and project discussions. Global Reach: Manage and develop relationships with international leads, with a focus on clients in the USA. Creative Marketing: Design innovative marketing materials and strategies, oversee domain and CRM systems, manage websites, and drive social media engagement to boost brand visibility.Essential Requirements: Demonstrated success in sales and marketing, with a strong track record of meeting or exceeding targets. Existing network of contacts in biotechnology, pharmaceutical, nutraceuticals, and clinical research organizations. A biotech or science degree combined with robust marketing expertise is highly desirable. A highly motivated individual with a proven ability to adapt, innovate, and drive business growth. Willingness and ability to travel nationally and internationally to foster client relationships and represent MusB Research.Compensation: Competitive base salary with commission-based incentives tied to performance. Comprehensive annual perks and benefits package.

About Clinogenesis Research Institute:Clinogenesis Research Institute is a premier training and research organization dedicated to advancing careers in clinical research, bioinformatics, and life sciences. With a focus on providing comprehensive training and career support, we work closely with industry partners to ensure that our students and interns gain relevant experience and are well-prepared for career success.Position Overview:We are seeking motivated and detail-oriented Clinical Research Interns to join our team. This role provides a unique opportunity to gain hands-on experience in clinical research while working alongside experienced professionals. Interns will assist in various stages of clinical trials, data collection, and analysis, gaining essential skills in research practices and regulatory compliance.Responsibilities:Assist in the design, planning, and execution of clinical trials and research projects.Collect, review, and organize clinical data from research studies.Support data entry, verification, and ensure data quality and compliance with regulatory standards.Coordinate with cross-functional teams, including data management, biostatistics, and medical affairs.Prepare documentation, reports, and presentations for project updates and regulatory submissions.Maintain accurate study documentation and ensure adherence to GCP (Good Clinical Practice) and ethical guidelines.Qualifications:Currently pursuing or recently completed a degree in life sciences, clinical research, biostatistics, pharmacy, or a related field.Strong analytical skills and attention to detail.Ability to work effectively in a team-oriented environment.Proficiency in MS Office applications (Excel, Word, PowerPoint).Knowledge of GCP, ICH guidelines, and basic clinical trial processes is a plus.Excellent written and verbal communication skills.

Key Responsibilities:1. Trial Architecture:> Contribute to the development of dynamic trial plans and protocols in tandem with the clinical operations team.> Collaborate on the strategic selection and qualification of investigative sites.2. Site Symphony:> Conduct harmonious site initiation, monitoring, and close-out visits to ensure seamless protocol execution and pristine data collection.> Cultivate collaborative relationships with investigative site teams, providing support and guidance.3. Regulatory Mastery:> Ensure meticulous adherence to regulatory standards, guidelines, and the principles of Good Clinical Practice (GCP).> Spearhead the preparation and submission of regulatory documents to ethics committees and regulatory authorities.4. Data Choreography:> Direct the orchestration of data collection, ensuring the accuracy and completeness of clinical trial data.> Collaborate with data management teams to resolve data discrepancies and maintain a symphony of data quality.5. Risk Ballet:> Proactively identify potential risks to trial success and choreograph mitigation strategies in collaboration with project teams.6. Communication Sonata:> Cultivate clear and resonant communication channels with internal and external stakeholders.> Compose eloquent and timely study progress reports, fostering transparency and accountability.Qualifications:Bachelor's or advanced degree in a relevant field (Life Sciences, Nursing, etc.).Demonstrated experience as a Clinical Research Associate, preferably in the pharmaceutical or biotechnology domain.Profound knowledge of clinical trial processes, regulatory requirements, and GCP.Exceptional interpersonal and communication finesse

Position: Research And Development ApprenticeshipEligibility: LGBT Applicants Only + B.Pharm/M.Pharm (2022, 2023 or 2024 pass outs) + Bangalore City candidate***The above 3 parameters in Eligibility will be considered ONLY***Qualification: (2022, 2023 & 2024 Pass Outs) B. Pharm / M. PharmStipend: INR 25,000 per month (in hand)Duration: 12 monthsCTA: Depending on performance maybe be converted into full time resources at the end of the internship periodWork Timing, General Shift: 9AM to 5 PMLocation: Bengaluru OnlyWho Can Apply - LGBT+ (Lesbian, Gay, Bisexual, Transgender+) Pharma Job Seekers who are based in and around Bengaluru only Role Requirements-Good English language skills written and verbal particularly in scientific/medical terminologyAbility to evaluate data and draw conclusions with appropriate guidance from senior team members or managerGood attention to detailGood interpersonal, presentation and communication skillsService-oriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environmentComputer proficiency, IT skills, the expertise and ability to work with web-based applicationsGood level of flexibility and ability to prioritize workIf you belong from LGBT Community then please send CVs at pamela@thepridecircle.com

Position: Clinical Research CoordinatorQualification Bio Science (B.Pharm/Bio Tech etc.)Experience Above 1 Year (Clinical Research Experience must) Timing General ShiftSalary 2L 2.5L (Per annum)Location Visakhapatnam/Chennai/BangaloreLanguage Know English/Kannada/TeluguJOB Description Clinical Research Coordinator To have the good knowledge of regulations and GCP guidelines. Ability to communicate properly between the physician, patient & the site head. Assist Senior CRC in Screening including informed consent process, randomization, enrolment & follow-up (including Telephonic Follow-up) process & procedures. Maintenance of Investigator Master File as per Good documentation practices & SOP including generation of source documents. Present in Site Initiation Visit, Monitoring Visits, Site Closeout Visit. CRF, e-CRF entry, Data Query resolution. Coordinate between the local/Central laboratory and courier for the shipment. Assist the pharmacist in drug accountability and temperature maintaining logs. Assist the Sr. CRC in maintaining the accountability of study materials and in scheduling study procedures. Endow the required file notes, weekly and monthly and monthly report to the reporting authority. Tracking the status of all study activities. Report Sr.DGM daily and take advice for further action.

Company: TK-Chain Location: Hyderabad, ChennaiExperience: 5+Job Overview: We are seeking a dedicated Senior Statistical Programmer to join our dynamic team. You will be responsible for the development, quality control, and documentation of statistical (SAS) programming deliverables for clinical research studies.Key Responsibilities:1. Lead and oversee the development of SAS programs for the management and statistical analysis of clinical trial data.2. Develop, test, and validate statistical tables, listings, and graphs (TLGs) in support of the statistical analysis plan.3. Support the generation and review of protocols, data management plans, study reports, and other regulatory documents.4. Provide input to the statistical analysis plan, table shells, data integration plans, and mock-ups.5. Ensure data quality by designing and validating key data checks and listings.6. Develop specifications for derived datasets and perform data transformation as necessary.7. Collaborate effectively with data management and biostatistics teams, clinicians, and other project stakeholders.8. Guide junior programmers and provide mentoring as needed.9. Keep abreast of new developments in SAS programming and clinical research, and act as a subject matter expert for the team.Required Qualifications and Skills:1. Bachelor's or masters degree in Statistics, Mathematics, Computer Science, or a related field.2. Minimum of 3 plus years of statistical programming experience in the pharmaceutical, biotech, or CRO industry.3. Excellent SAS programming skills and proficiency in SAS/Base, SAS/Macro, SAS/Graph, and SAS/STAT.4. Familiarity with CDISC SDTM and Adam data standards.5. In-depth understanding of clinical trial data and extremely complex statistical methods.6. Excellent problem-solving skills and a proactive approach to identifying and resolving issues.7. Strong written and verbal communication skills, with the ability to translate complex data into

1) Identify new sites. PIs and conduct the detailed protocol specific feasibility.2) Preparation for site selection visit3) IRB submission & approval4) Regulatory document collection5) Set-up. maintain & timely update or Trial Master File(TMF) & relevant site binders Files6) Prepare site for Site Initiation Visit (SIV)7) Assisting Principal Investigator in administering the Informed Consent Form process8) Ensure protocol adherence and Compliance; t document protocol deviations as appropriate and communicate any impacting subject safety to !he Ethics Committee. 9) Pre-screening, screening, enrolling & recruiting subjects.10) Creating and Preparing Source Documents and their templates11) Coordinate and schedule subject's regular follow-up Visit and Procedures. preventing lost to follow-up & missed visits. Maintaining regular contact With Subject Telephonically12) Manage Clinical Trial Materials (CTM ). accountability, distribution & logistics at site13) Filling the case reports forms and Electronic case report forms and resolving all data queries within timelines.14) Reporting and coordinating all Adverse Events & Serious Adverse Events according to their timelines.15) Filling up and maintaining trial related logs like drug dispensing logs, subject logs. investigational Product t Logs, temperature logs. Etc. 16) Maintaining Calibration records of Instrument used for the trials.17) Preparing Site for monitoring & audit visits. Coordinate close out visit & archival at site.18) Communicating all protocol-related issues problems to the appropriate management staff including but not limited to questions regarding the conduct of clinical trials. Concerns regarding possible serious adverse events or subject compliance.19) Co ordinate central lab logistics & sample flow. Review lab data & communicate abnormal values to the primary care provider(if appropriate) & investigator.20) Co ordinate subject reimbursements.21) Performing all the above activities i

Perform core medical monitoring activities for multiple assigned studies, including input into study design, protocol and regulatory approval strategy, Prepare and execute successful SEC Presentation in CDSCO meetings. Response to inquiries from the sites, regulatory authorities, IRBs/IECs Responsibility for the management of all medical issues which arise in the course of the clinical study (Phase II IV/PMS), presentation to investigator meetings, safety review committees. Write the study Medical Monitoring Plan (MMP) in co-ordination with the Safety Monitoring Plan (SMP) Perform the medical review of patient data and patient profiles during the study period and provide input for the clinical study report (CSR). Provide medical oversight of assigned studies, including medical monitoring, evaluation of patients eligibility, interpretation and appropriate management and reporting of patient safety data throughout the lifecycle of the study in accordance with ICH Good Clinical Practice, applicable regulatory guidelines and company standard operating procedures. Review adverse events (AEs), serious adverse events (SAEs) and AEs of Special Interest, and participate in safety signal detection activities to identify emergent safety concerns and recommend appropriate action. Provide medical expertise, guidance, and therapeutic area training of project team as required. Act as medical advisor to project manager when required. Guide Statistics Analysis Team during Data Analysis for CSR.

Primary responsibilities are clinical programming and data analysis; understanding various data sources and coding programs to extract data into analysis-ready data sets; creation of software test plans and testing, and development of statistical analysis reports. Data analysis includes descriptive analysis of Independent Reader performance and other metrics to assess the quality of services offered by WCC. Clinical Programmer works closely with Project Managers, Software Developers and Clients regarding data quality and data transfers.Essential Functions Lead clinical programming aspects of WCC clinical trials, including consulting with external statistical consultants. Analyze existing and new programs, processes and databases to identify and/or guide implementation of modifications aimed at increasing workflow efficiency. Develop SAS databases, when applicable Review and assure the quality, integrity, accuracy, and completeness of clinical trial data based on project specific guidelines. Develop and implement quality review of data using SAS data validation programs. Standardize datasets to ensure compliance with data transfer requirements and enhance usability. Develop programs and guide efforts to perform robust data manipulation and error detection to ensure data integrity. Extract data from the WCC trial system and provide analytical reporting. Review data exports and reports to identify, investigate and reconcile data discrepancies with Clinical Operations staff and/or clients Data Managers. Implement variability testing criteria to monitor Independent Reader performance. Author and review Data Transfer Files specifications (DTF) for incoming and outgoing data files. Respond to client requests for additional data and/or data analysis, as needed. Collaborate effectively and build productive relationships within across the global operations team. Performs other job-related duties as assigned.

B.E / B.Tech (Computer and IT Branch only) / B.Sc. IT / B.C.A (Fresher) 2022 Batch

Quality review of ICSRs, surveillance of known or emerging safety issues, participation in an escalation process, risk evaluation, and analysis of safety data. Apply safety concepts and regulations contained within FDA CFR, ICH, and EU GVP to management of Safety data across the development life cycle. Analyze aggregate safety data within a clinical program towards tracking and trending of risk assessments and additional mitigation measures. Contributes to safety sections of the investigational new drug and new drug applications, investigator or regulator communications, Investigator brochure, and other reports (DSUR) Participates in the set-up and maintenance of adverse event processes in global clinical trials Ensure Quality of the Individual Case Safety Report, including data and a concise, medically relevant narrative.