10 Ichgcp Guidelines Jobs

As a Clinical Research Associate II (Sponsor dedicated) in Athens Homebase at Syneos Health, you will play a crucial role in ensuring site compliance with regulatory guidelines and protocol requirements. Your responsibilities will include performing site qualification, initiation, monitoring, management activities, and close-out visits either on-site or remotely. You will assess site performance, provide recommendations, and escalate any serious issues to the project team promptly. Your attention to detail will be essential as you verify the informed consent process, assess factors affecting subject safety, and review clinical data for accuracy and completeness. You will conduct source document reviews, resolve queries, and ensure site compliance with electronic data capture requirements. Additionally, you may be involved in investigational product inventory, reconciliation, and storage reviews. Maintaining accurate documentation, such as confirmation letters, follow-up letters, and trip reports, will be part of your routine tasks. You will support subject recruitment and retention strategies, enter data into tracking systems, and manage site-level activities to meet project objectives within specified timelines. Your adaptability to changing priorities and ability to communicate effectively with study site personnel will be crucial for success in this role. As a Clinical Research Associate II, you will also participate in Investigator Meetings, sponsor meetings, and clinical training sessions. You will work towards audit readiness standards, prepare for audits, and ensure compliance with applicable regulatory requirements. Your knowledge of Good Clinical Practice guidelines and relevant regulations will guide your actions throughout the study lifecycle. To excel in this role, you should hold a Bachelor's degree or RN in a related field, have knowledge of ICH Guidelines and regulatory requirements, possess strong computer skills, and be willing to travel up to 75% of the time. Excellent communication skills, the ability to work collaboratively, and a commitment to maintaining high standards of quality and compliance are essential for success in this position. Join us at Syneos Health, where you will have the opportunity to make a meaningful impact on the lives of patients and contribute to the advancement of healthcare through innovative clinical research practices. Discover a rewarding career with a global organization that values diversity, inclusivity, and professional growth. Visit our website to learn more about Syneos Health and the exciting opportunities we offer.,

You will be joining our Clinical Operations team in India, Mumbai as a full-time office-based Experienced Study Start-up Submissions Coordinator. Your role will be crucial in accomplishing tasks and projects that are essential for the success of our company. If you are seeking a rewarding career where you can utilize your expertise and further develop and grow professionally, this opportunity is perfect for you. At Medpace, we foster a culture of expertise and empowerment, allowing our teams to leverage their unique talents and experiences to approach research and problem-solving assertively, thereby supporting our business partners effectively. Our employees embody our values and commitment to serving our clients, working diligently, meeting high expectations, and embracing challenges. In return, they receive engaging projects, opportunities for career advancement, and exposure to our international presence. These are some of the reasons why talented individuals choose to be part of the Medpace team. Your responsibilities will include: - Performing necessary activities within the country to activate investigative sites for clinical trials across all phases. - Preparing, reviewing, and submitting documents to Regulatory Agencies. - Communicating with global study teams and personnel to update them on study progress. - Identifying and mitigating risks related to site activations effectively. - Providing expertise and guidance to global study teams regarding ethics and regulatory submissions. - Reviewing and finalizing essential documents required for site activation. - Serving as the main contact for Ethical and Regulatory submission-related activities. - Engaging directly with investigative sites during the study start-up and activation process. - Ensuring that submissions comply with relevant regulations and guidance documents. - Advising sponsors on changing regulations and compliance requirements. - Tracking submissions and ensuring timely filing of documents. Qualifications required: - Bachelor's degree in a scientific field or equivalent education and experience. - Minimum of 4 years of relevant work experience at a CRO, Pharmaceutical Company, or investigative site. - Strong organizational and communication skills. - Proficiency in Microsoft Office, ICH-GCP guidelines, and regulatory guidelines. - Hands-on experience in preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies, including responding to queries. - Proficiency in English language. About Medpace: Medpace is a full-service clinical contract research organization (CRO) offering Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. We leverage local regulatory and therapeutic expertise in various major areas, including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective. With headquarters in Cincinnati, Ohio, we have a workforce of over 5,000 employees spread across 40+ countries. Why Choose Medpace: At Medpace, we believe in People, Purpose, and Passion. We offer a flexible work environment, competitive compensation and benefits package, structured career paths for professional growth, company-sponsored employee appreciation events, and health and wellness initiatives for employees. Our work has been recognized by Forbes as one of America's Most Successful Midsize Companies and we have received numerous CRO Leadership Awards for expertise, quality, capabilities, reliability, and compatibility from Life Science Leader magazine. What to Expect Next: If your qualifications align with our requirements, a Medpace team member will review your profile and contact you with further details regarding the next steps in the process. Thank you for considering a career with us.,

As the Manager of Data Management at eClinical Solutions, you will be responsible for providing operational leadership in overseeing end-to-end data management services for designated projects and studies in modern clinical data management. Your role will involve collaborating closely with clients and vendors to ensure timely delivery of high-quality outputs within budgetary constraints. You will strategically integrate advanced technologies and data science techniques to enhance the efficiency and quality of clinical trials within our organization, aiming to improve operational effectiveness and scientific rigor in data management practices. Your key tasks and responsibilities will include: - Acting as the key scientific and technical data management expert - Defining and driving data management strategy and standards for Therapeutic Areas (TA) and Risk Based Monitoring (RBM) - Managing the data management delivery team and developing capabilities to support workload and organizational growth - Ensuring Data Management deliverables meet project/study team expectations - Serving as a subject matter expert in end-to-end study execution - Managing a team of study leads for data management tasks - Providing technology expertise and guidance for business development/sales opportunities - Developing staff and setting performance targets - Participating in expert working groups and innovation discussions - Championing elluminate DM tools - Providing project and strategic consulting while delivering quality and optimizing efficiencies - Executing data management strategies to leverage clinical data through elluminate Data Central - Fostering customer relationships for account growth and repeat business - Monitoring project financials and key performance indicators - Interacting with vendors to ensure data needs are met - Ensuring compliance with quality standards and guidelines - Addressing issues proactively and promoting training programs for staff - Representing data management at industry meetings/conferences The ideal candidate should have a Bachelor's degree in a health-related field or equivalent experience, with 15+ years of experience in the Life Sciences industry preferred. CCDM certification is also preferred. Strong project management, data management, and EDC experience are required, along with proficiency in Microsoft Office applications and knowledge of ICH/GCP guidelines and clinical trial methodology. Experience with EDC and Clinical Data Management Systems, such as Medidata Rave, is preferred, as well as familiarity with data reporting tools like Qlik and Spotfire. Candidates should have demonstrated leadership skills, client relationship management experience, and the ability to motivate and mentor staff effectively. If you are looking to accelerate your skills and career within a fast-growing company that impacts the future of healthcare, eClinical Solutions welcomes you to join our inclusive and diverse team. We are committed to creating an environment where individual experiences inspire innovation, learning, and continuous improvement. Bring your authentic self and contribute to our people-first organization that values diversity and equal opportunity.,

As a Clinical Trials Assistant, you will play a crucial role in supporting various aspects of clinical trials. Your responsibilities will include assisting in site selection, initiation, monitoring, and close-out visits for clinical trials to ensure their successful implementation. It will be your responsibility to ensure that all clinical trials are conducted in compliance with the protocol, ICH-GCP guidelines, and regulatory requirements. You will be tasked with maintaining accurate and proper documentation of all trial activities and reporting findings effectively. Your role will also involve supporting data verification by meticulously comparing source data with Case Report Forms (CRFs). Effective communication with investigators and site staff will be essential to address and resolve any issues that may arise during the trials. In addition, you will be expected to assist in tracking project timelines and deliverables to ensure the smooth progression of the trials. It will also be necessary for you to attend training sessions regularly to stay updated with the latest regulatory guidelines and industry standards. This is a full-time, permanent position suitable for freshers who are looking to kickstart their career in the field of clinical trials. The benefits of this position include health insurance, paid sick time, and Provident Fund. The work location for this role is in person, providing you with a hands-on experience in the clinical trials environment.,

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 Senior Clinical Data Manager I to join our A-team (hybrid*). The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. In this role, you will manage, coordinate, review, and approve DM deliverables from database design & set-up, through cleaning and reporting to database locking. It is crucial to ensure that the completeness, accuracy, and consistency of clinical data meet the quality standards and regulatory requirements for analysis and reporting. Additionally, you will provide expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. You will also be involved in Request for Proposals (RFPs) and present at Business Development (BD) Meetings. As a Senior Clinical Data Manager I, your key tasks will include: - Leading and serving as the primary contact for DM with all relevant parties internally and externally - Planning and projecting the resources required including management of tasks, timelines, risk, and quality - Developing, reviewing, and maintaining project-specific DM documents throughout the project lifecycle - Leading and coordinating the development of clinical study database set-up, eCRF design, and database validation requirements - Creating training materials for EDC users and providing project-specific training - Overseeing data cleaning strategy, data releases, data transfers, and reconciliation activities - Providing project metric reports, status updates, study progress, and feedback to the project team - Maintaining DM study documentation, supporting internal and external audits, and aligning data management and clinical programming best practices - Participating in client evaluations, preparing new proposals and budgets for Data Management services, and staying updated on regulatory development trends Requirements: - Life science, healthcare degree and/or combination of education and experience - Minimum 5 years of relevant work experience as a Clinical Data Manager - Thorough knowledge of ICH-GCP, 21CFR11 data privacy guidelines, and awareness of local/regional requirements - Experience with EDC software systems, IRT, eCOA, and CDISC conventions - Strong written and verbal communication skills, organizational, negotiating, and motivational skills - Ability to work in a fast-paced challenging environment and proficiency with computer applications Benefits of working at Allucent include: - Comprehensive benefits package - Competitive salaries - Departmental Study/Training Budget for professional development - Flexible working hours and remote/office-based working opportunities - Leadership and mentoring opportunities - Internal growth opportunities, employee referral program, and access to online training platforms *This position is for the Chennai Location and not home-based** *Please note that Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any open roles. Candidates should never be submitted directly to hiring managers, employees, or human resources.*,

As a Medical Safety Expert, your primary responsibility will be to provide medical safety expertise to Sponsors of drugs, devices, and combination products during the post marketing period. This will involve undertaking the primary medical review of cases, including assessing seriousness, listed/labeling, causality, adverse event coding, and narrative review. You will be required to update and document case data daily, provide training and guidance to the case processing team on medical aspects, and ensure all assigned deliverables meet quality, compliance, and productivity standards. Additionally, you will perform secondary medical reviews and retrospective reviews to measure the quality of deliverables, identify error trends, and contribute to process improvement activities. Your role may also involve aggregate medical review and signal detection/analysis activities. It is essential to maintain client relationships, promote a culture of high customer service, and participate in enhancing processes across the company. To qualify for this position, you must hold a Bachelor's degree in medical science, MD, DO, or equivalent. Relevant experience may be considered in lieu of educational requirements. Proficiency in English at ILR level 3+ for speaking and level 4+ for writing/reading is required. You should have a working knowledge of medical sciences, diagnosis, therapeutics, drug treatments, regulatory requirements for Clinical Research, and ICH-GCP guidelines. Preferred qualifications include a good understanding of regulatory requirements related to Pharmacovigilance and up to 2 years of experience in the pharmaceutical industry, particularly in pharmacovigilance or clinical research. Clinical practice experience of 1 to 2 years is also preferred. This role may involve working in an office or home-based environment as requested by the line manager. Your dedication to ensuring high-quality deliverables, maintaining strong client relationships, and contributing to process improvements will be key to your success in this role.,

As the Principal Investigator (PI) based in Noida, India, you will play a crucial role in overseeing the scientific, ethical, and regulatory aspects of clinical trials. Your responsibilities will include ensuring participant safety, protocol adherence, and data integrity throughout the trial process. You will collaborate with sponsors, regulatory authorities, and internal teams to achieve successful trial outcomes. Your key responsibilities will involve serving as the lead medical expert for assigned clinical trials, ensuring compliance with ICH-GCP guidelines and local regulatory requirements, overseeing patient recruitment and informed consent processes, documenting and reporting adverse events, participating in protocol development, and providing clinical oversight and training to site staff. To be considered for this role, you must hold an MBBS degree, possess a valid medical license to practice in India, and have at least 13 years of experience in clinical trials. Prior experience as a Principal Investigator or Sub-Investigator is highly desirable. In-depth knowledge of regulatory frameworks such as ICH-GCP, CDSCO, FDA, and EMA is essential, along with strong leadership, communication, and analytical skills. Preferred skills for this role include experience in early-phase or late-phase clinical trials, familiarity with electronic data capture systems, and prior participation in audits or regulatory inspections. It is important to note that only MBBS-qualified doctors who are willing to operate out of Noida should apply for this position. If you are interested in this opportunity, please reach out directly to express your interest and share your updated CV with Elden.mathew@skylimitresearch.com.,

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 Senior Clinical Data Manager I to join our A-team in the Chennai location. The Senior Clinical Data Manager I (SrCDM1) will be responsible for leading data management activities of the Allucent Data Management (DM) department. In this role, your key tasks will include leading and serving as the primary contact for DM with all relevant parties both internally and externally, planning and projecting the resources required, monitoring tasks against budgets and forecasts, and developing, reviewing, and maintaining project-specific DM documents. You will also lead and coordinate the development of clinical study database set-up, participate in the review of study documents, coordinate database User Acceptance Testing (UAT), create training materials for EDC users, oversee data cleaning and validation, and manage various data transfers and reconciliation activities. Additionally, you will provide project metric reports, status updates, study progress, and feedback to the project team, organize and lead Quality Review activities during the study, assist in project-related contracts negotiation, and manage the database maintenance, lock, and close-out processes. You will also participate in conference calls and meetings with vendors and sponsors, maintain DM study documentation, support internal and external audits, align data management and clinical programming best practices, and provide leadership and support to other department members. To be successful in this role, you should possess a life science or healthcare degree, a minimum of 5 years of relevant work experience as a Clinical Data Manager, thorough knowledge of ICH-GCP, 21CFR11 data privacy guidelines, and experience with electronic data capture software systems. You should also have experience as a DM lead on several studies, strong written and verbal communication skills, strong project management skills, and the ability to simplify complex issues into understandable concepts. Benefits of working at Allucent include a comprehensive benefits package, competitive salaries, departmental study/training budget, flexible working hours, opportunity for remote/office-based working, leadership and mentoring opportunities, internal growth opportunities, access to online training, eligibility for Spot Bonus Award Program, and eligibility for Loyalty Award Program. Please note that office-based employees are required to work in-office for a minimum number of days per work week. Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on open roles. Candidates should never be submitted directly to hiring managers, employees, or human resources.,

The Lead Biostatistician is a key member of the Department of Biostatistics & Programming, responsible for performing all Biostatistics tasks essential for clinical trial analysis and reporting. Collaborating closely with the Statistical Programming, Data Management, and Product Development departments, this position involves leading projects across studies or programs. As the primary contact with the sponsor for all biostatistics related activities on assigned projects, you will direct the activities of other biostatisticians to ensure timely completion of high-quality work. Your responsibilities include providing statistical support for clinical studies, developing and reviewing statistical analysis plans, monitoring statistical analysis programs, and collaborating with functional management to meet project deliverables and timelines. In addition, you will perform all SAS programming required for analysis and reporting, plan and execute SAS programs to analyze clinical trial data, and conduct quality control checks on assigned tasks. Your role also involves maintaining high productivity on projects, identifying and communicating resource and quality issues, resolving data interpretation and reporting issues, complying with regulatory requirements, and independently solving technical problems. To qualify for this position, you should hold a minimum of a master's degree in Statistics and have at least 8 years of experience as a Biostatistician and Statistical Programmer for all clinical trial phases. Proficiency in industry standards, CDISC data standards, ICH-GCP guidelines, medical terminology, and clinical trial methodologies is essential for success in this role.,

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients" lives. Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership, and Integrity. We aim to be the Clinical Research Organization that delivers excellence to our clients and patients at every touchpoint, aspiring to be the partner of choice in drug development. If you share our vision and are as driven as we are, join us. You'll be working in a dynamic and supportive environment with some of the brightest and friendliest people in the sector, helping to shape an industry. As a Due Diligence Specialist, you will be responsible for performing extensive Due Diligence/Compliance Checks on all potential Investigators for Site ID I SSU according to ICON and Sponsor specific procedures. Your role will involve updating appropriate documentation and the ICON investigator database with all relevant information. Some key responsibilities include: - Conducting Freedom of Information (FOi) Check and World Check, ECAC (Ethics Compliance Accreditation Certificate) updates - Updating information and study teams feedback from the Quality Assurance department on Investigators with critical findings - Assisting with various queries related to Due Diligence information in the database - Running reports/searches from the system as requested - Ensuring all internal and external customers receive the appropriate level of service and response from the due diligence team - Actively participating in data analysis projects and initiatives - Networking and collaborating with other professionals, attending and presenting at meetings both internally and externally - Undertaking other duties as assigned from time to time To be successful in this role, you will need: - Previous monitoring experience in medium-sized studies, including study start-up and close-out - Knowledge of ICH-GCP guidelines and the ability to review and evaluate medical data - Ability to work effectively to tight deadlines Benefits of Working in ICON: We prioritize building a culture that rewards high performance and nurtures talent. We offer competitive salary packages benchmarked regularly against competitors, annual bonuses reflecting performance goals, health-related benefits for employees and their families, competitive retirement plans, life assurance, and more. You'll benefit from an environment where you are encouraged to fulfill your sense of purpose and drive lasting change. If you require a reasonable accommodation due to a medical condition or disability during any part of the application process or to perform the essential functions of a position, please let us know through the form provided.,