11 Ich Gcp Jobs

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step. As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity. Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program. Summary The Senior Regulatory Specialist is the subject matter expert and leader of a regulatory team to prepare and maintain complete and accurate regulatory documents in support of clinical research studies. Role & Responsibilities Leads a team of multiple regulatory specialists supporting one or more Velocity Clinical Research sites Ensures regulatory submissions are done in a timely manner as to not delay study start up. Prepare each study specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRB. Prepare and submit amendments, yearly requests for continuing approval of open protocols, audits, adverse event reports, and any other IRB-required submissions. Work with staff members to complete conflict of interest paperwork for each study. Assist new hires in completing and submitting all required research documentation and trainings. Track training status for existing staff, assisting with updates as needed. Maintain study binder with all IRB related documents and correspondence for each study. Maintain electronic regulatory files, including tracking document history. Maintain a database of staff listings and training dates. Pro-actively notify staff and Site Manager/Director of upcoming training expiration dates to maintain compliance Coordinate meetings with auditors to review paper and electronic regulatory files and inspectors. Provide copies of IRB documents to sponsors, as needed. Adhere to safety and compliance regulations. Stay abreast of evolving regulatory trends and work with the Site Manager/Site Director to ensure compliance with changes in the regulations Ensures binder accuracy, completeness and inspection readiness Prepare local IRB submissions Review ICFs for completeness - ensure the California Bill of Rights is included as applicable, subject stipends are accurate, and all protocol procedures are captured in the ICF Ensures that ICFs and other study documents are available in any language as required by the site and approved by the IRB Works with the Velocity IRB of record to submit generic site material Other duties as assigned Education/Experience Bachelors degree and 4 years of clinical research regulatory experience OR Associates degree with 6 years of clinical research regulatory experience OR High School Graduate and/or technical degree with minimum of 8 years of clinical research regulatory experience Required Licenses/Certifications None Certified Clinical Research Professional a plus Required Skills Proficient in the use of the following technology Computers, Microsoft Office software, fax, copier, and multi-line telephone. Proficient ability to work in a fast paced environment Advanced verbal, written, and organizational skills Advanced interpersonal and communication skills Advanced ability to work as a team player Advanced ability to read, write, and speak English Demonstrated ability to multi-task Demonstrated ability to mentor and train Advanced ability to follow written guidelines Proficient ability to work independently, plan and prioritize with minimal guidance Proficient ability to be flexible/adapt according to the needs of the clinic priortization Must be detailed oriented and can demonstrate attention to detail Proficient problem solving and strategic decision making ability. Advanced in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised Proficient leader, mentor an team builder Advanced understanding of ICH, GCP, and FDA regulatory requirements Required Physical Abilities Sit or stand for long periods of time Travel locally and nationally Communicate in person and by a telephone Limited walking required Limited to lifting up to 30 pounds NOTE The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management. Show more Show less

As a Site Activation Specialist I at Syneos Health in Beijing/Shanghai, you will be responsible for ensuring the quality of deliverables at the country level, adhering to project requirements and applicable country rules under the oversight of the SSU Country Manager. Your role will involve working within forecasted submission/approval timelines, tracking milestone progress in real-time, and providing clear rationale for any delays while assisting in developing contingency plans to mitigate impacts. You will also monitor basic financial aspects of the project, escalate discrepancies promptly, and comply with Standard Operating Procedures (SOPs) and Work Instructions (WIs) while keeping training records updated. Your responsibilities will include ensuring all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements. Additionally, you will be involved in functions such as Local Submissions Specialist, Local Site ID and Feasibility Support, and Local Investigator Contract and Budget Negotiator at the country level. You will collaborate with investigative site personnel, oversee site activation processes, and facilitate interactions between investigational sites and functional leads. To qualify for this role, you should have an Associate degree or equivalent combination of education and training. A good understanding of the clinical trial process across Phases II-IV and ICH GCP is essential, along with effective communication skills and the ability to handle multiple tasks with attention to detail. You should be able to work independently and as part of a team, adapt to changing environments, and demonstrate strong computer skills. At Syneos Health, we are committed to developing our employees through career progression, supportive management, training programs, and a total rewards program. We value diversity, inclusivity, and a culture where everyone feels they belong. Join us in accelerating the delivery of therapies and making a difference in the lives of patients globally. *Note: This job description is not exhaustive, and additional tasks may be assigned at the Company's discretion. The Company values equivalent experience, skills, and education, and will determine qualifications accordingly. This job description does not create an employment contract.*,

As a Regional Submission Manager - Sponsor-dedicated with CTIS experience at Syneos Health, you will play a crucial role in driving regional submission management strategy and activities for assigned protocols. You will collaborate with major functional areas, including SSU and Study Management, regarding essential core documents and local documentation needed from relevant supplier lines across both HA and EC submission and translation processes. Your responsibilities will include partnering with study teams to manage required regulatory activities, standards, and deliverables associated with CTA submission development. You will be responsible for authoring Annex I and completing relative associated documentation as required. Additionally, you will lead global team efforts to ensure high-quality components and submissions that are compliant with industry, agency, and format guidelines, regulatory strategies, policies, and timelines. In this role, you will prepare, review, and support submissions to HA/Regional CTA Hub to obtain all necessary authorizations/approvals related to the clinical trial conduct. You will also be responsible for coordinating translations for core documents required for submission and managing the compilation for core package build, contributing to CTA and authoring documentation as necessary. Furthermore, you may act as a local country liaison when required and escalate, inform, and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities. To qualify for this position, you should have a Bachelor's Degree (Higher Degree Preferred) and independent CTIS experience in initial submission and substantial amendments. You should have the ability to work on multiple highly complex projects simultaneously and possess a strong knowledge of the drug development process, regulatory sciences, CTA and submission management, and publishing. It is essential to have an in-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experience in process development and new technology implementation. Additionally, you should be able to operate seamlessly and influence direct and indirect reports across the organization. Demonstrated understanding of regional and national regulator filing guidelines and dossier requirements is required, along with the ability to lead and deliver through others in a matrix model. Strong decision-making skills in ambiguous or urgent circumstances, excellent communication, presentation, and interpersonal skills, as well as quality-driven and negotiating abilities are also essential for this role. Join Syneos Health to be part of a dynamic team that is passionate about accelerating customer success and changing lives through innovative clinical development solutions. Discover the rewarding career opportunities that await you at Syneos Health.,

As a Safety & PV Specialist II at Syneos Health, you will play a crucial role in entering information into PVG quality and tracking systems for receipt and tracking of ICSR as required. You may also assist in preparing project plans such as Safety Management Plan and perform set-up, delivery, and close-out of safety and pharmacovigilance projects. Your responsibilities will include processing ICSRs according to SOPs and project-specific safety plans, triaging ICSRs, evaluating data for completeness and accuracy, and entering data into safety databases. Additionally, you will code events, medical history, concomitant medications, and tests, compile complete narrative summaries, and follow up on information queries until satisfactorily resolved. You will participate in the generation of expedited reports in accordance with regulatory requirements, coordinate safety data reconciliation between clinical and safety databases, and perform activities related to SPOR/IDMP. Furthermore, you will conduct quality reviews of ICSRs, serve as a subject matter expert in SPVG, and ensure compliance with regulatory guidelines and project plans. To qualify for this role, you should have a Bachelor's Degree in life science, nursing, pharmacy, or equivalent education and experience. Proficiency in safety database systems, medical terminology, and understanding of clinical trial processes is essential. You should have excellent communication skills, the ability to work independently and in a team, and strong organizational skills to prioritize tasks effectively. Minimal travel may be required for this position. Join Syneos Health, an organization that values career development, diversity, and creating a supportive work environment. As part of our team, you will have the opportunity to contribute to the development of life-changing therapies and make a difference in the lives of patients worldwide. Learn more about Syneos Health by visiting our website at http://www.syneoshealth.com. Please note that tasks and responsibilities outlined in this job description are not exhaustive, and additional duties may be assigned at the company's discretion. Qualifications may vary based on equivalent experience, skills, and/or education. The Company is committed to providing reasonable accommodations under the Americans with Disabilities Act to assist employees in performing essential job functions.,

As a Site Activation Specialist at Syneos Health in Shanghai or Beijing, you will be responsible for ensuring the quality of deliverables at the country level while adhering to project requirements and applicable country rules under the oversight of the SSU Country Manager. You will work within the forecasted submission/approval timelines, track milestone progress, and provide clear rationale for any delays while assisting with contingency plans to mitigate impacts. Monitoring basic financial aspects of the project and ensuring compliance with SOPs and WIs will also be part of your responsibilities. Your role will involve submitting essential documents to the Trial Master File (TMF) as per Company SOP/Sponsor requirements and handling various functions at the country level. This may include acting as a Local Submissions Specialist, overseeing site activation processes, providing feasibility support, and negotiating investigator contracts and budgets. To excel in this role, you should have an Associate degree or equivalent combination of education and training, a good understanding of clinical trial processes, and the ability to interact effectively with investigative site personnel. Strong organizational skills, attention to detail, and the ability to work independently or as part of a team are essential. Additionally, you should be adaptable to changing environments, possess strong computer skills, and be quality-driven in all managed activities. Joining Syneos Health means being part of a dynamic organization that is committed to developing its people, fostering a supportive culture where authenticity is valued, and creating a diverse and inclusive work environment. If you are passionate about making a difference in the world of biopharmaceutical solutions and are ready to collaborate with a team of dedicated professionals, this opportunity is for you. Please note that the tasks, duties, and responsibilities outlined in this job description are not exhaustive, and the Company may assign additional responsibilities at its discretion. Qualifications may vary based on equivalent experience, skills, and education. The Company is committed to compliance with all relevant legislation and providing reasonable accommodations under the Americans with Disabilities Act when necessary.,

As a Site Activation Specialist II at Syneos Health, you will be responsible for ensuring quality deliverables at the country level while following project requirements and applicable country rules under moderate oversight from the SSU Country Manager. You will work within forecasted submission/approval timelines, track milestone progress in the SSU tracking system, and investigate any delays with clear rationale and contingency plans as needed. Additionally, you will monitor basic financial aspects of the project, review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WI), and support the continuous improvement of quality in all Site Start-Up (SSU) components. Your role will involve ensuring all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements. You may be responsible for functions such as Local Submissions Specialist, Country Start-Up Advisor, Local Site ID and Feasibility Support, or Local Investigator Contract and Budget Negotiator at the country level. Depending on your assignment, you will follow project direction, prepare submissions, provide support with site selection, negotiate contracts and budgets, and ensure quality control and execution of contracts. To be successful in this role, you should hold a Bachelor's Degree and have a detailed understanding of the clinical trial process across Phases II-IV and ICH GCP. Strong organizational, communication, interpersonal, and problem-solving skills are essential, along with the ability to manage multiple tasks effectively. Your role will contribute to the overall success of clinical trials and research projects by efficiently and effectively managing the site identification process in accordance with regulations, SOPs, and project requirements. Join us at Syneos Health, where you will collaborate with passionate problem solvers to accelerate the delivery of therapies and change lives. Discover the opportunities to develop your career, be part of a supportive and engaged team, and contribute to creating a workplace where everyone feels like they belong. Your work here matters everywhere. Please note that the tasks, duties, and responsibilities mentioned in this job description are not exhaustive, and the Company may assign additional tasks at its discretion. The Company values equivalent experience, skills, and education, and will consider qualifications beyond those listed in the Job Description. Compliance with all obligations imposed by relevant legislation, including the provision of reasonable accommodations, is a priority for the Company.,

About ProcDNA: ProcDNA is a global rocket ship in life sciences consulting. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 300+ across 6 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. Ready to join our epic growth journey We are currently seeking a Programmer Analyst with a strong hands-on experience in EDC platforms such as Medidata RAVE, InForm, Central Designer, or Veeva Studio. The ideal candidate will possess a solid understanding of clinical data standards, protocol interpretation, and the ability to build high-quality, compliant EDC databases. As a Programmer Analyst, you will play a crucial role in supporting the end-to-end development of clinical databases and ensuring data integrity throughout the trial lifecycle. Your responsibilities will include interpreting clinical trial protocols to design eCRFs and build databases using Medidata RAVE, InForm, Central Designer, or Veeva Studio. You will be responsible for configuring systems, implementing edit checks, dynamic rules, and custom functions (C# for RAVE) based on DVS. Additionally, you will conduct technical and functional reviews, support Sponsor Acceptance Testing (SAT), and ensure accuracy across all database components. You will also manage protocol amendments, metadata updates, lead ICRM/SAM meetings, and resolve issues in QC, UAT, and production environments. Handling migrations, RFCs, and post-go-live activities, generating sponsor reports (JReview, SAS, BOXI), acting as DB Coordinator across trials, and mentoring junior team members will also be part of your role. Key Requirements: - 3 to 5 years of hands-on experience with at least one EDC platform such as Medidata RAVE, InForm, Central Designer, or Veeva Studio (combination preferred). - Proficiency in eCRF design, edit checks, dynamic rules, and custom functions (e.g., C# for RAVE). - Solid understanding of clinical trial protocols, DVS interpretation, CDPS/SDV strategy, CRF annotation, and post-go-live activities, including migrations and RFCs. - High attention to detail with strong adherence to ICH GCP and clinical data standards. - Excellent written and verbal communication skills for effective team and sponsor collaboration. - Educational background in BE/B.Tech, M.Sc./MCA, or B.Sc./BCA in Computer Science or a related stream with consistent academic performance of 60% or above in 10th, 12th, and graduation.,

As a Safety & Pharmacovigilance Specialist I at Syneos Health, you will play a crucial role in ensuring the safety and well-being of patients involved in clinical trials and post-marketing programs. Your responsibilities will include entering information into PVG quality and tracking systems, processing ICSRs according to SOPs, and evaluating ICSR data for completeness and accuracy. You will be responsible for triaging ICSRs, entering data into safety databases, coding events, medical history, and concomitant medications, as well as compiling complete narrative summaries. Additionally, you will be involved in identifying information to be queried, following up until resolution, and generating timely and accurate expedited reports in compliance with regulatory requirements. Your role will also involve maintaining safety tracking for assigned activities, performing literature screening and review for safety, drug coding, and MedDRA coding as required. You will validate and submit xEVMPD product records, manually recode un-recoded product and substance terms from ICSRs, identify and manage duplicate ICSRs, and conduct activities related to SPOR/IDMP. Furthermore, you will ensure the submission of all relevant documents to the Trial Master File and the Pharmacovigilance System Master File, while maintaining compliance with SOPs, global regulations, and guidelines. You will foster professional relationships with project team members, participate in audits as required, and apply safety reporting regulatory intelligence to all safety reporting activities. To excel in this role, you should possess a Bachelor's Degree in life science, registered nurse, pharmacist, or an equivalent combination of education and experience. A minimum of 3 years of experience in ICSR is required, along with a good understanding of clinical trial processes, ICH GCP, GVP, and safety regulations. Proficiency in Microsoft Office Suite, excellent communication skills, the ability to work independently and in a team environment, and strong organizational skills are essential. Join Syneos Health, a company dedicated to accelerating customer success by translating insights into outcomes and creating a diverse and inclusive workplace where everyone feels like they belong. If you are passionate about making a difference in the lives of others, apply now and be a part of our team that is committed to changing lives through innovative solutions.,

As a Clinical Research Associate (CRA), you will play a key role in conducting Phase I-IV clinical BA/BE studies. Your primary responsibilities will involve monitoring and managing activities at clinical sites to ensure that project timelines and deliverables are achieved. Building strong relationships with clinical sites and investigators will be essential, along with assessing protocol and regulatory compliance based on local and federal requirements, ICH GCP guidelines, and PSI SOPs. Your focus will be on safeguarding subjects" rights, safety, and well-being, as well as maintaining data quality. Your tasks will include preparing, conducting, and reporting on various activities such as site selection, initiation, routine monitoring, and close-out visits. Monitoring patient enrollment to meet recruitment targets and project timelines will be crucial at both site and country levels. You will be responsible for source data verification, resolving data queries, and conducting ongoing reviews to ensure data quality and compliance with Risk Based Monitoring practices. Timely reporting and follow-up of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations will also be part of your duties. Acting as the main communication channel between the Sponsor and the site, you will serve as a point of contact for in-house support services and vendors. Proper handling, accountability, and reconciliation of Investigational Product(s) and study supplies will be under your supervision. Additionally, you will review essential documents at the site level and ensure the reconciliation of study OSF/TMF at the site and/or country level.,

Excelya is a leading independent Contract Research Organization (CRO) in Europe, dedicated to providing a people-centered approach since its inception in 2014. As a part of the ambitious health company, with a team of 900 Excelyates, our unique service model offers a diverse array of projects, enabling professional growth and personal development. In collaboration with experts, Excelya aims to advance scientific knowledge and enhance the patient journey, striving to become the clinical research leader in Europe. As a Clinical Data Manager at Excelya, you will be responsible for executing Data Management tasks in compliance with regulatory standards and Client SOPs. Working under the supervision of senior staff, you will be involved in data cleaning, review, discrepancy management, and reconciliation activities on assigned studies. Additionally, you will collaborate with the Lead Data Manager, generate study metrics and reports, and participate in study documentation archiving. Excelya is currently seeking a Full Service Provider role of Clinical Data Manager I (CDMI) based in Bangalore, India. The role requires a candidate with a Bachelor's degree in a Scientific discipline, preferably with at least one year of experience as a Data Manager or relevant expertise. Knowledge of ICH GCP guidelines, clinical trial databases, data flow, and proficiency in office computer applications are essential requirements for this position. Effective communication skills, both verbal and written, along with a commitment to professionalism, ethics, and compliance, are key attributes we are looking for in potential candidates. The successful candidate for the role of Clinical Data Manager at Excelya should be fluent in both the local language and English. This full-time position is located in Bangalore and offers an opportunity to contribute to the field of Clinical Research. If you are passionate about making a difference in the healthcare industry and meet the mentioned requirements, we encourage you to apply for this exciting opportunity. If you are interested in this position, please reach out to Bhavya Reddy, HR Manager, for further details.,

Data Management Manager Location: Bangalore Experience: 10+ years Education: Science Graduate Notice Period: Immediate Joiners preferred Skills: Data management, Line management, ICH GCP, data management FSP, clinical study, QC,