45 Clinical Monitoring Jobs

The Associate Medical Expert in Translational Clinical Oncology (TCO) serves as the medical leader for global, roll-over, and long-term follow-up studies, as well as studies in the close-out phase. Additionally, they provide medical support for assigned components of active TCO studies under the guidance of a Clinical Program Leader (CPL) or Medical Expert. TCO, a department within the Biomedical Research division, specializes in designing and conducting early-phase clinical studies in cancer patients, bridging the gap between drug discovery and late-phase clinical development to deliver innovative oncology treatments. In this role, your major responsibilities include providing medical support to CPL and/or Medical Expert, contributing to clinical sections of various documents, participating in safety reporting activities, preparing submission documents for health authorities, overseeing clinical trial data review, and ensuring quality and consistency in clinical study reports. You will also be involved in dose escalation meetings, site initiation visits, and the publication of study findings. Key Performance Indicators for this position include demonstrating high-quality medical input to ensure adherence to timelines and regulations, conducting thorough reviews of clinical trial data, and exhibiting strong scientific writing skills. Your performance will be evaluated based on your contributions to the department's objectives, feedback from stakeholders, and alignment with Novartis Values and Behaviors. To qualify for this role, you must hold an MD or equivalent medical degree, possess advanced knowledge and clinical training in a relevant area, and have experience in hematology/oncology. Preferred qualifications include at least 2 years of industry experience or 4 years of clinical practice, along with familiarity with Good Clinical Practice (GCP) and strong project management skills. In addition to technical skills such as clinical monitoring, research, and regulatory compliance, the ideal candidate should demonstrate effective decision-making, excellent communication abilities, and a track record of building positive relationships. Fluency in English is required for this role. Novartis offers a collaborative and supportive environment where dedicated professionals can make a meaningful impact on patients" lives. If you are passionate about driving innovation in healthcare and working with a community of like-minded individuals, we invite you to join us in creating a brighter future together. For more information about Novartis and our commitment to helping individuals and families affected by diseases, visit: https://www.novartis.com/about/strategy/people-and-culture If this role does not align with your career aspirations, you can sign up for our talent community to stay informed about future opportunities: https://talentnetwork.novartis.com/network To learn about the comprehensive benefits and rewards offered by Novartis, please refer to our handbook: https://www.novartis.com/careers/benefits-rewards,

Welcome to the new and exciting Central Monitoring Head role - we are open for applications! As the incumbent, you will need to be a visionary, strategic leader and thrive in driving functional excellence in clinical trial monitoring. With the new 2025 regulations in place, you will be responsible for building-up and overseeing state-of-the-art Central Monitoring capabilities while advancing field monitoring. This opportunity entails building new processes, growing a team, solidifying relationships in a global matrix environment, overseeing data trends, and incorporating new technologies. To be a successful applicant, you will need to possess excellent communication skills, embrace innovation, collaborate effectively, be agile, empathetic, empower others, manage resistance, and have a superior clinical trial knowledge with a thorough understanding of the field monitoring landscape. In this role, you will have major accountabilities including establishing and implementing a Clinical Monitoring function at Novartis, defining and executing Clinical Monitoring strategies, developing and optimizing Clinical Monitoring resourcing strategy, as well as actively monitoring objectives in line with GCO priorities and industry benchmarks. Additionally, you will need to collaborate with stakeholders, coordinate cross-functional interactions, and act as a key connector between Central Monitoring, global Risk Surveillance team, and field monitoring functions. Your leadership and change management skills will be crucial in guiding the organization through the transition to a Central Monitoring model, driving cultural and operational change, and acting as a champion for innovation. To be considered for this role, you should hold a University degree in life science, business, or operations with an Advanced degree preferred. You should have at least 10 years of recent pharmaceutical industry experience, with previous experience in clinical research, in a Pharmaceutical Industry or CROs, as well as 6 years of recent experience in people management and/or team leadership. A thorough understanding of international aspects of the drug development process, strong technical and analytical problem-solving skills, and fluency in English are also required. Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. If you are ready to take on this challenging yet rewarding role, apply now to create a brighter future together at Novartis.,

Premier Research is looking for a Medical Specialist to join our Medical Affairs 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 here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What youll be doing: The Medical Specialist (MPs) is responsible for supporting members of the medical team (i.e. Medical Monitors (MM), Medical Scientists (MS), and other functional leads) to perform and execute all project deliverables associated with a clinical trial in accordance with all applicable regulations, standards, and study-specific requirements. Partners with the MM and MS across all therapeutic areas at Premier Research to support overall project delivery through coordination and oversight of broad study needs. This may include tracking of safety data, document maintenance in accordance with applicable study regulations (including keeping document logs and collections) and providing planning and scheduling assistance for internal and external activities, and FDA regulated documentation. Independently responsible for managing and overseeing the 24/7 staff physician tracker and process in accordance with FDA regulation, including: managing vendor relationship, liaising with associated therapeutic area/BU, conducting test calls, maintaining associated SOPs, triaging medical information. Collects study-specific data reports, compiling specified documents, and modifying Premier Research-approved templates to study-specific and protocol needs. Provides document formatting and the display of select data/information or summaries, as needed. Assists with 21 CFR Part 11 document compliance and facilitates document handling for the MM, as well as tracks and supports the capture of these documents into the Trial Master File (TMF). Supports other activities for TMF documents for the medical team under specifications of the MM. Provides project template customization including Word documents and PowerPoint slide decks to the specification of the medical team. Develops and independently maintains tracking tools for select safety concerns to the specifications of the lead MM for individual studies, as well as tracking of study participants during the pre-enrollment eligibility process (PEER) as applicable. Assists with the Data Monitoring Committee/Data and Safety Monitoring Board/Safety Review Committee (DMC/DSMB/SRC) meeting planning and preparations for the medical team, following the specifications of and under the supervision of the MM/MS, and supports recurring medical data reviews and DMC/DSMB meetings with document collection and distribution to MM/MS. Supports all therapeutic areas in the setup, development, and maintenance of study specific data displays using Clinical Trial Management Software. Assists MM/MS in facilitating team communications and maintaining documentation internally and externally. Ensures effective communication by scheduling internal and external team meetings. Develops and independently maintains Medical Affairs team study tracker, proactively identifies gaps, and promptly alerts the MM/MS teams to critical issues. Acquires additional information and skills to enhance job performance, maintain an up-to-date knowledge of Premier Research systems, services, policies and procedures. Participates in corporate initiatives and actions that ensure the continued success of the company. What we are looking for: Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field and a minimum of 2 years of clinical research experience or Bachelor s degree, or international equivalent, preferably in a clinical, biological, scientific, business, or health-related field, and a minimum of 1 year of professional work experience in clinical research, healthcare, business, finance, and/or project management preferred. Strong computer skills in MS office suite required. Basic knowledge of ICH/GCP regulations. Working knowledge of FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures. Basic knowledge of project management terminology and guidelines a plus.

Premier Research is looking for a Medical Specialist to join our Medical Affairs 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 here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What youll be doing: The Medical Specialist (MPs) is responsible for supporting members of the medical team (i.e. Medical Monitors (MM), Medical Scientists (MS), and other functional leads) to perform and execute all project deliverables associated with a clinical trial in accordance with all applicable regulations, standards, and study-specific requirements. Partners with the MM and MS across all therapeutic areas at Premier Research to support overall project delivery through coordination and oversight of broad study needs. This may include tracking of safety data, document maintenance in accordance with applicable study regulations (including keeping document logs and collections) and providing planning and scheduling assistance for internal and external activities, and FDA regulated documentation. Independently responsible for managing and overseeing the 24/7 staff physician tracker and process in accordance with FDA regulation, including: managing vendor relationship, liaising with associated therapeutic area/BU, conducting test calls, maintaining associated SOPs, triaging medical information. Collects study-specific data reports, compiling specified documents, and modifying Premier Research-approved templates to study-specific and protocol needs. Provides document formatting and the display of select data/information or summaries, as needed. Assists with 21 CFR Part 11 document compliance and facilitates document handling for the MM, as well as tracks and supports the capture of these documents into the Trial Master File (TMF). Supports other activities for TMF documents for the medical team under specifications of the MM. Provides project template customization including Word documents and PowerPoint slide decks to the specification of the medical team. Develops and independently maintains tracking tools for select safety concerns to the specifications of the lead MM for individual studies, as well as tracking of study participants during the pre-enrollment eligibility process (PEER) as applicable. Assists with the Data Monitoring Committee/Data and Safety Monitoring Board/Safety Review Committee (DMC/DSMB/SRC) meeting planning and preparations for the medical team, following the specifications of and under the supervision of the MM/MS, and supports recurring medical data reviews and DMC/DSMB meetings with document collection and distribution to MM/MS. Supports all therapeutic areas in the setup, development, and maintenance of study specific data displays using Clinical Trial Management Software. Assists MM/MS in facilitating team communications and maintaining documentation internally and externally. Ensures effective communication by scheduling internal and external team meetings. Develops and independently maintains Medical Affairs team study tracker, proactively identifies gaps, and promptly alerts the MM/MS teams to critical issues. Acquires additional information and skills to enhance job performance, maintain an up-to-date knowledge of Premier Research systems, services, policies and procedures. Participates in corporate initiatives and actions that ensure the continued success of the company. What we are looking for: Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field and a minimum of 2 years of clinical research experience or Bachelor s degree, or international equivalent, preferably in a clinical, biological, scientific, business, or health-related field, and a minimum of 1 year of professional work experience in clinical research, healthcare, business, finance, and/or project management preferred. Strong computer skills in MS office suite required. Basic knowledge of ICH/GCP regulations. Working knowledge of FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures. Basic knowledge of project management terminology and guidelines a plus.

Major accountabilities: Provides medical support to Clinical Program Leader (CPL) leading the program. Medical support may include, but is not limited to, contributing to clinical sections of protocols and/or amendments, Informed Consents, publications, regulatory documents such as Investigator Brochures, responses to Health Authority questions and conducting ongoing review of clinical trial data, with oversight of TCO deliverables. May act as the medical monitor to support overall program safety reporting (e.g., Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety Team. May represents CPL at project team meetings (e.g. CTT) and may provide inputs to project strategy May represent CPL at Investigator teleconferences including dose escalation meetings and site initiation visits. Oversees the clinical/scientific elements of TCO - related submission documents, including preparation and review of project documentation for Health Authority submission, including briefing books, IBs, Annual Safety Reports, responses to Health Authority questions etc. Leads the ongoing clinical trial data medical/scientific review across assigned TCO studies and coordinates data analysis and interpretation Accountable for assigned close-out, roll-over and long-term follow-up studies, ensuring Clinical Study Report review, consistency and quality of clinical study reports (CSR) in collaboration with CSR medical writing team, and publication of studies across assigned TCO projects - either directly as lead author or by providing leadership to the medical writing team Manages stakeholder engagements internally and externally Mentors and coaches junior TCO team members in India Maintains expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies. Leads or assists with relevant trainings across TCO India Advocate continuous improvement of quality Ensure all activities of associates comply with company standards and local regulations Key performance indicators: Management of assigned studies to ensure execution according to timelines, and with high quality, ensuring adherence to international and local regulations. Demonstrates excellent scientific writing skills to enable the development of quality trial reporting, and regulatory documents. Strong evidence of quality medical review of trial data and quality contributions to clinical sections of e.g. protocols, IBs, DSURs and CSRs Contribution towards objectives set for the department. Feedback from external and internal stakeholders. Clearly demonstrates Novartis Values and Behaviors. Minimum Requirements: Education: MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine / pharmacology etc.) with medical council certification required. Experience in hematology / oncology preferred Work Experience: At least 5 years of pharmaceutical/biotech industry experience At least 2 years of clinical practice experience in the hospital setting. Experience with oncology clinical trials Experience with early development clinical trials Knowledge of Good Clinical Practice (GCP). Strong operational project experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities. Demonstrated operational excellence and scientific contribution to both clinical and preclinical projects. Strategic thinking: ability to network with and influence key stakeholders, clear and logical presentation of complex strategic issues. Clear written and verbal expression of ideas, an active/proactive communicator. Well-developed interpersonal skills, with a proven record of accomplishment of successfully interacting with, influencing and building strong positive relationships. Used to working independently and in a team, being flexible and adapting in a changing environment. Skills: Clinical Monitoring. Clinical Research. Clinical Trial Protocol. Clinical Trials. Decision Making Skills. Drug Development. Health Sciences. Lifesciences. Medical Strategy. Regulatory Compliance. Languages : English. Skills Desired Clinical Monitoring, Clinical Research, Clinical Trial Protocol, Clinical Trials, Decision Making Skills, Drug Development, Health Sciences, Lifesciences, Medical Strategy, Regulatory Compliance

As a Clin Ops Specialist/CTA based in Athens, your role at Syneos Health will involve performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions. You will assist Clinical Monitoring staff with site management activities, serving as a Sponsor representative for assigned studies and ensuring compliance with protocol requirements and relevant guidelines by communicating with sites. Additionally, you will create and assist with maintenance of Trial Master File (TMF) and project files, participate in file audits, prepare site manuals and other documents, update clinical tracking information databases, and track incoming and outgoing clinical and regulatory documents. Your responsibilities will also include managing a shared mailbox, processing site requests, coordinating the ordering, packaging, shipping, and tracking of site supplies and materials, assisting with team meetings, preparing accurate meeting minutes and action items, handling receipt, tracking, and disposition of Case Report Forms and Queries, and maintaining awareness in the field of clinical research through necessary training. To excel in this role, you should possess a High School diploma or equivalent, good communication and interpersonal skills, and the ability to embrace new technologies. Some travel, up to 25%, may be required as part of the role. Syneos Health is dedicated to developing its employees through career progression, supportive line management, technical and therapeutic area training, peer recognition, and a comprehensive total rewards program. The company is committed to fostering a Total Self culture where authenticity is valued, and diversity of thoughts, backgrounds, cultures, and perspectives are embraced to create an inclusive work environment. If you are passionate about making a difference in the field of clinical research, and eager to work in a dynamic and innovative environment where your contributions matter, Syneos Health offers a rewarding opportunity to be part of a global organization that is driven to accelerate the delivery of therapies and change lives. Discover more about Syneos Health and the impactful work we do by visiting http://www.syneoshealth.com. Please note that the tasks, duties, and responsibilities outlined in this job description are not exhaustive, and the company reserves the right to assign additional responsibilities at its discretion. Qualifications may vary based on equivalent experience, skills, and education. Moreover, this description does not create an employment contract, and the company is committed to compliance with relevant legislation to ensure equal opportunities for all employees. Additionally, reasonable accommodations will be provided as per the Americans with Disabilities Act to assist employees or applicants in performing essential job functions.,

As a Sr CRA I based in Beijing at Syneos Health, you will play a crucial role in monitoring clinical research studies to ensure they are conducted in line with established clinical practices. You will be responsible for both on-site and remote monitoring, developing tools, procedures, and processes to maintain quality monitoring standards. Your dedication to contributing to the design, implementation, and delivery of processes and programs will be instrumental in the success of clinical research studies. Syneos Health is committed to fostering a supportive and engaging work environment where career development, progression, and peer recognition are prioritized. As part of our Total Self culture, you will be encouraged to be your authentic self as we believe that diversity of thoughts, backgrounds, and perspectives contributes to a workplace where everyone feels a sense of belonging. In your role, you will ensure regulatory compliance throughout various stages of clinical trials such as site qualification, initiation, monitoring, management, and close-out visits. Your duties will also include evaluating site performance, protecting patient confidentiality, verifying clinical data accuracy, and managing site-level activities to meet project objectives and timelines. At Syneos Health, you will have the opportunity to collaborate with a team of passionate problem solvers who are dedicated to accelerating the delivery of therapies and changing lives. With a global presence across 110 countries and a diverse workforce, you will be part of a company that is continuously evolving to create a workplace that employees are proud to be a part of. If you are a motivated individual with a background in clinical monitoring and a commitment to upholding the highest standards of clinical research practices, we invite you to join us in our mission to make a meaningful impact on healthcare outcomes. Please note that the responsibilities listed in this job description are not exhaustive and additional tasks may be assigned at the company's discretion. Qualifications may vary based on equivalent experience, skills, and education. Syneos Health is an equal opportunity employer committed to compliance with all applicable regulations and ensuring a supportive and inclusive workplace for all employees.,

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.,

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. We are seeking a dynamic Manager to join our Life Sciences Consulting team, specializing in Clinical Operations transformation. This role involves working with global pharmaceutical, biotech, and medtech clients to optimize R&D and clinical delivery models, streamline operations, and implement emerging technologies across clinical development. Experience: 7-10 years Education: M.Tech / M.Sc / Ph.D. in Life Sciences, Biotechnology, Pharmacology, Clinical Research, or related disciplines Preferred Background: Life Sciences Consulting | Clinical R&D | Clinical Operations Strategy Key Responsibilities: - Lead and manage client engagements focused on clinical operations transformation, process improvement, and technology enablement. - Design operating models, workflows, and KPIs for clinical development functions. - Collaborate with cross-functional teams (regulatory, safety, data management) to align clinical strategies with enterprise goals. - Prepare business cases, PoVs, and transformation roadmaps for clients. - Support proposal development and go-to-market (GTM) strategies in the clinical domain. - Mentor junior consultants and contribute to knowledge building within the practice. Must-Have Skills: - Strong understanding of the clinical development lifecycle (from trial design through close-out). - Demonstrated experience in managing/leading consulting engagements. - Exposure to CRO management, site selection, clinical monitoring, or clinical project management. - Excellent communication, stakeholder management, and analytical skills. Nice-to-Have Skills: - Familiarity with technologies like SDTM, CDISC, CTMS, eTMF, or EDC systems. - Prior experience with clinical digital transformation initiatives (e.g., decentralized trials, risk-based monitoring). - Certifications in clinical project management or data standards (e.g., CCDM). EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people, and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform, and operate. Working across assurance, consulting, law, strategy, tax, and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.,

At Allucent, we are dedicated to assisting small-medium biopharmaceutical companies in efficiently navigating the complex world of clinical trials to bring life-changing therapies to patients in need globally. We are currently seeking a Sr. Clinical Research Associate Contractor (SrCRA) to join our A-team on a remote basis for 0.5Fte. As a SrCRA Contractor at Allucent, you will be responsible for independently controlling and monitoring investigational sites, proactively identifying issues, and providing solutions to ensure that clinical studies are conducted according to the trial protocol and in compliance with SOPs, relevant regulations, and the principles of Good Clinical Practice. Your key responsibilities will include maintaining the highest quality standards for trial monitoring activities, ensuring all study tasks are conducted in compliance with quality standards, monitoring activities at clinical study sites to guarantee adherence to protocols and guidelines, preparing and submitting quality Site Visits Reports, updating CTMS in compliance with SOPs, acting as Document Owner for collected documents, offering functional assistance to project team members, liaising with project team members and sponsors to track study progress, supervising data collection, and representing Allucent in the global medical research community. To be successful in this role, you should have at least five years of clinical monitoring experience, a relevant life science degree or medical/nursing background, a strong understanding and application of Good Clinical Practices and Standard Operating Procedures, excellent communication skills, the ability to work in a fast-paced environment, proficiency in computer applications, and the capability to travel an average of 8 days on-site per month. Additionally, you should possess in-depth knowledge of clinical trials, the drug development process, and medical terminology, as well as the ability to proactively identify and resolve issues, manage multiple projects, and establish effective working relationships. Please note that office-based employees are required to work in-office for a minimum of two days per work week. Allucent does not accept unsolicited resumes from third-party recruiters and candidates should not be submitted directly to hiring managers. Join us at Allucent and be part of our mission to bring life-changing therapies to patients worldwide!,

The GCP Compliance Manager (GCO) is responsible for overseeing and controlling compliance of regulated GCO activities, focusing on those with a high impact on GCO's ability to meet objectives. This role plays a crucial part in supporting GCP Compliance pillars, including issue management, audits, and inspections, particularly system/process audits and global inspections for authorizations and GCO self-strategy delivery. As the GCP Compliance Manager (GCO), you will provide GxP expertise and support GCP Compliance for various functions, compliance, process, training, and risk groups. Your responsibilities will include managing systemic quality issues, deviations, quality events, audits, and inspections, as well as coordinating risk assessments across GCO functions. You will work under the leadership of the GCP Compliance Head (GCO) to execute the GCO GCP Compliance strategy, collaborating with relevant functions across GCO and the wider organization. Additionally, you will contribute to maintaining a compliance culture within GCO, promoting adherence to high standards and ethical integrity. Your key performance indicators will focus on crisis management, compliance of regulated GCO activities, enhancement of capabilities, timely delivery of self-assessment strategies, and contribution to product quality and compliance targets. The ideal candidate will have an advanced degree in science, engineering, or a relevant discipline, with at least 8 years of industry experience in clinical operations. Strong organizational, analytical, critical thinking, risk management, and communication skills are essential, along with the ability to work independently and make difficult decisions. Novartis offers a supportive community of passionate individuals dedicated to making a difference in patients" lives. By joining Novartis, you can collaborate with like-minded professionals to achieve breakthroughs that positively impact patient outcomes. If you are looking to be part of a diverse and inclusive work environment that values personal and professional growth, consider joining Novartis in Hyderabad, India, to contribute to innovative medicines and research and development. For more information on Novartis and career opportunities, visit https://www.novartis.com/about/strategy/people-and-culture and https://talentnetwork.novartis.com/network.,

As a Senior Clinical Operations Specialist (Senior CTA) in the Hybrid model in Athens at Syneos Health, you will play a crucial role in ensuring compliance with Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions. Your responsibilities will include assisting Clinical Monitoring staff with site management activities, maintaining project files, handling project correspondence, participating in file audits, and preparing and maintaining site manuals and reference tools. Additionally, you will be responsible for updating clinical tracking information into databases, tracking documents, managing the shared mailbox, and coordinating site supplies and materials. You will collaborate with sites on assigned studies, communicate with them to ensure compliance with protocol requirements and relevant guidelines, and serve as a Sponsor representative. Your role will also involve anticipating, identifying, and resolving potential issues, implementing corrective actions, and seeking guidance as needed for more complex matters. Furthermore, you will participate in team meetings, prepare accurate meeting minutes and action items, and maintain awareness of clinical research by completing all necessary training. To excel in this role, you should preferably have an Associate's degree or equivalent experience in clinical research, pharma, biotech, or a related field. Good knowledge of medical terminology, clinical data, and ICH/GCP is preferred. You should possess strong organizational skills, attention to detail, and the ability to prioritize and work on multiple tasks. Excellent communication, presentation, and interpersonal skills are essential, along with the willingness to embrace new technologies. Minimal travel of up to 10% may be required as part of your responsibilities. At Syneos Health, we are committed to developing our employees through career progression, supportive line management, training programs, peer recognition, and a total rewards program. Our Total Self culture encourages authenticity and fosters a sense of belonging among our diverse workforce. By joining us, you will become part of a team dedicated to accelerating the delivery of therapies and changing lives. Syneos Health has a strong track record, having worked on a significant number of FDA-approved drugs, EMA authorized products, and numerous studies across various sites and trial patients. In our dynamic and competitive environment, you will be empowered to challenge the status quo and drive innovation. If you are passionate about making a difference in the field of clinical research and are looking for a challenging yet rewarding opportunity, consider joining Syneos Health. Learn more about us at http://www.syneoshealth.com.,

Role & responsibilities Participate in the investigator recruitment process. Perform initial qualification visits of potential investigators and sites. Evaluate the capability of the site to successfully manage and conduct the clinical study, both clinically and technically. Work with the Study Start-up Group to coordinate activities with the site in preparation for the initiation of studies. Obtain regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Perform study initiation activities, reviewing with the site study team the protocol, regulatory issues, study procedures, and provide training on completion of the e-CRF; monitoring activities and study close-out activities. Train site study team on the EDC system. Conduct periodic site file audits to ensure compliance with GCPs and sponsors standard operating procedures. Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Perform validation of source documentation as required by sponsor. Prepare monitoring reports and letters in a timely manner as per Clinical Trial Monitoring Plan. Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Perform investigational product inventory. Ensure return of unused materials to designated location. Review the quality and integrity of the clinical data through in house review of electronic CRF data and on-site source verification. Work with sites to resolve data queries. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Coordination with central and corelab (Echocardiography, QCA, OCT/IVUS, ECG) involved in the clinical trial. Review protocols, eCRFs, ICF and other related documents, as requested by Project Manager. Assist with final date review and query resolution through database lock. Online & offline regulatory/IEC submissions of different countries. Coordination with DSMB, Steering committee, CEC and attend meetings and prepare minutes of meetings. Preparation of study presentation for review meetings at Central Drug Standard Control Organization Regulatory Body of India. Preparation of Study presentation for national & international conferences.

- 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)

Minimum Qualifications BA or BS degree Experience in CRO or Pharmaceutical industry Ability to prioritize activities effectively to accomplish individual and team goals with competing deadlines Ability to write and speak clearly and concisely in a variety of communication settings and styles Strong interpersonal skills; ability to establish and promote positive business relationships; customer service oriented Ability to collaborate with study staff and internal and external partners to achieve goals Proficient computer skills including use of MS Office Suite (Word, Excel, PowerPoint) and enterprise clinical trial management systems Strong organizational skills and attention to detail Strong problem analysis and resolution skills Knowledge of site management and clinical monitoring for clinical research studies

Clinical Trial Associate (CTA) provides essential administrative and operational support to clinical trial teams, assisting with tasks related to document management, regulatory compliance, communication, and data management. CTAs play a crucial role in ensuring trials are conducted efficiently and ethically, and in accordance with established guidelines. Here's a more detailed breakdown: Key Responsibilities: Document Management: CTAs are responsible for creating, collecting, organizing, and maintaining essential study documents, including protocols, informed consent forms, case report forms, and study plans. Regulatory Compliance: They ensure all trial-related activities adhere to relevant regulations and guidelines, such as Good Clinical Practice (GCP). Communication: CTAs facilitate communication between the study team, sponsors, and other stakeholders, including investigators, vendors, and regulatory bodies. Administrative Support: They provide general administrative support to the clinical operations department, including scheduling meetings, preparing presentations, and managing travel arrangements. Data Management: CTAs assist with data entry, cleaning, and quality control, ensuring data integrity and accuracy. Study Tracking: They track study progress, maintain study metrics, and generate reports to monitor trial performance. Other Tasks: CTAs may also be involved in tasks such as investigator and third-party payments, site contract management, and management.

The clinical operations activities at our organization are expanding rapidly, and we are currently looking for a full-time Clinical Research (CRA) Manager to join our Clinical Monitoring team in Navi Mumbai, India. In this role, you will play a crucial part in the clinical trial management process at Medpace. If you are seeking a challenging career where you can utilize your existing expertise and further develop and advance your professional journey, then this opportunity is perfect for you. Your responsibilities will include: - Managing a team of Clinical Research Associates (CRAs) - Recruiting, providing initial and ongoing training, and fostering the development of CRAs - Overseeing and managing CRAs to ensure they fulfill their core monitoring responsibilities effectively - Tracking and managing CRA resourcing and assignment allocation - Handling turnover and retention of CRAs to align with company objectives To qualify for this position, you should have: - A Bachelor's degree with 4-6 years of experience in the pharmaceutical industry, specifically in clinical monitoring or study management, with at least 3 years as a CRA and 1-2 years as a CRA Manager preferred - Advanced knowledge of Good Clinical Practice - Strong leadership, mentoring, and motivational skills - Effective written and verbal communication abilities - Proficiency in Microsoft Office software - Willingness to travel occasionally for evaluating CRAs (approximately 10% of the time) Medpace is a comprehensive clinical contract research organization (CRO) that offers Phase I-IV clinical development services to biotechnology, pharmaceutical, and medical device industries. Our mission is to expedite the global advancement of safe and effective medical therapeutics through a scientific and disciplined approach. With headquarters in Cincinnati, Ohio, we have a workforce of over 5,000 individuals spread across 40+ countries. At Medpace, we believe in People, Purpose, and Passion. By joining us, you can make a difference tomorrow. The work we have accomplished in the past three decades has positively impacted numerous patients and families dealing with various diseases across key therapeutic areas. The work we undertake today will enhance the lives of individuals living with illness and disease in the future. In addition to a fulfilling work environment, we offer: - Flexible work arrangements - Competitive compensation and benefits package - Generous PTO packages - Structured career paths with prospects for professional growth - Company-sponsored employee appreciation events - Employee health and wellness initiatives Medpace has been honored with several awards, including being recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024. We have also consistently received CRO Leadership Awards from Life Science Leader magazine, acknowledging our expertise, quality, capabilities, reliability, and compatibility. If you are interested in this opportunity, a Medpace team member will review your qualifications and reach out to you with further details on the next steps.,

The Associate Medical Expert in Translational Clinical Oncology (TCO) plays a crucial role as the medical leader for various global studies, roll-over studies, long-term follow-up studies, and studies in the close-out phase. Working under the guidance of a Clinical Program Leader (CPL) and/or Medical Expert, you will provide essential medical support for assigned aspects of active TCO studies. TCO is a department within the Biomedical Research division that focuses on designing and conducting early phase clinical studies in cancer patients, aiming to develop innovative treatments for oncology conditions and bridge the gap between drug discovery and late-phase clinical development. In this role, your major responsibilities include providing medical support to the CPL and/or Medical Expert, contributing to clinical sections of protocols, Informed Consents, publications, regulatory documents, and ongoing review of clinical trial data. You may also act as the medical monitor for program safety reporting, contribute to submission documents for Health Authorities, review and analyze clinical trial data, and support various meetings and visits related to TCO studies. As the Associate Medical Expert, you will be accountable for overseeing close-out, roll-over, and long-term follow-up studies, ensuring the quality and consistency of clinical study reports in collaboration with the medical writing team. Your performance will be measured based on the quality of medical input to studies, scientific review of data, scientific writing skills, contribution to department objectives, feedback from stakeholders, and demonstration of Novartis Values and Behaviors. To qualify for this role, you must hold an MD or equivalent medical degree with advanced knowledge and clinical training in a relevant area, preferably hematology/oncology. You should have at least 2 years of experience in the pharmaceutical/biotech industry or 4 years of clinical practice experience, along with expertise in Good Clinical Practice (GCP) and strong operational project management skills. Excellent communication, interpersonal, and decision-making skills are essential for success in this position. In addition to technical skills, you should be a proactive team player, adaptable to changing environments, and committed to continuous improvement. Fluency in English is required for this role. By joining Novartis, you will be part of a community dedicated to making a positive impact on patients" lives through innovative science and collaborative teamwork. If you are looking to be part of a diverse and inclusive work environment where your contributions are valued, this role at Novartis may be the opportunity you've been seeking. Join us in creating a brighter future together and explore the possibilities of a rewarding career with Novartis.,

As a Clinical Research (CRA) Manager at Medpace, you will play a crucial role in the clinical trial management process within our growing clinical operations team in Navi Mumbai, India. Your responsibilities will include line management of Clinical Research Associates (CRAs), overseeing recruitment, training, and development of CRAs, ensuring CRAs meet core monitoring responsibilities, managing CRA resourcing and allocation, as well as addressing turnover and retention to align with company objectives. To excel in this role, you should hold a Bachelor's degree with 4-6 years of experience in the pharmaceutical industry, specifically in clinical monitoring or study management. Ideally, you should have spent at least 3 years as a CRA and 1-2 years as a CRA Manager. Advanced knowledge of Good Clinical Practice is essential, along with strong leadership, mentoring, and communication skills. Proficiency in Microsoft Office software is required, and occasional travel for evaluating CRAs is expected (approximately 10% of the time). Medpace is a renowned full-service clinical contract research organization dedicated to accelerating the global development of safe and effective medical therapeutics. With expertise in various therapeutic areas such as oncology, cardiology, and central nervous system disorders, we operate in over 40 countries with a team of over 5,000 professionals. At Medpace, you will find a supportive work environment that values People, Purpose, and Passion. We offer competitive compensation and benefits packages, flexible work arrangements, structured career paths for professional growth, and employee appreciation events. Our commitment to employee health and wellness initiatives underscores our dedication to creating a positive workplace culture. Join us at Medpace and be part of a team that has been recognized by Forbes as one of America's Most Successful Midsize Companies multiple times. Our continuous receipt of CRO Leadership Awards speaks to our expertise, quality, reliability, and compatibility in the industry. If you are looking to make a real difference in the field of healthcare and contribute to improving the lives of patients worldwide, submit your qualifications for review. A member of the Medpace team will reach out if there is interest in moving forward with the next steps.,

Key Responsibilities Design, plan, and oversee clinical trials from initiation to closeout Develop study protocols, informed consent forms, and case report forms Ensure compliance with GCP, ICH, and local regulatory guidelines Manage trial budgets, timelines, and resources Coordinate with CROs, investigators, and ethics committees Monitor trial progress and resolve operational issues Review and analyze clinical data for accuracy and integrity Prepare reports and presentations for internal and external stakeholders Train and mentor clinical research staff Support regulatory submissions and audits Qualifications & Skills M.Pharm / M.Sc / MBBS / MD in Life Sciences, Pharmacy, or Medicine 8-12 years of experience in clinical research, with at least 3 years in a managerial role Strong knowledge of clinical trial design, GCP, and regulatory frameworks

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.

Role Responsibilities: Deliver full-spectrum nursing care in clinical settings. Support physicians during medical procedures and surgeries. Monitor vital signs and patient responses to treatments. Maintain precise and up-to-date patient records. Job Requirements: Graduate or postgraduate in nursing. Experience in hospital or surgical environments. Strong clinical and observational skills. Ability to work collaboratively in a multidisciplinary team.

The Medical Expert in TCO (Translational Clinical Oncology) serves as the medical leader for assigned global, roll-over, and long-term follow-up studies, as well as studies in the close-out phase. Additionally, they may provide medical co-leadership for assigned aspects of global, active TCO studies under the guidance of a Clinical Program Leader (CPL). TCO, a department under the Biomedical Research division, is responsible for designing and conducting early-phase clinical studies in cancer patients, acting as a connection between drug discovery and late-phase clinical development to deliver innovative medicines for oncology conditions. Responsibilities include providing medical support to the CPL, contributing to clinical sections of protocols, Informed Consents, publications, regulatory documents, and reviewing clinical trial data. The Medical Expert may also oversee program safety reporting, represent the CPL at project team meetings and Investigator teleconferences, and lead the review of TCO submission documents. Furthermore, they are responsible for managing close-out, roll-over, and long-term follow-up studies, ensuring the quality of clinical study reports, and engaging with stakeholders internally and externally. The Medical Expert mentors junior team members, maintains expertise in regulations and procedures, and advocates for continuous improvement of quality. Key performance indicators include managing studies within timelines and regulatory standards, demonstrating strong scientific writing skills, providing quality medical review of trial data, contributing to department objectives, and receiving positive feedback from stakeholders. The role requires adherence to Novartis Values and Behaviors. Minimum Requirements: - MD or equivalent medical degree with clinical training and certification - At least 5 years of pharmaceutical industry experience - At least 2 years of clinical practice experience - Experience in hematology/oncology preferred - Knowledge of GCP and oncology clinical trials - Strong project management, communication, and interpersonal skills - Ability to work independently and in a team, adapt to changing environments, and network effectively Skills: - Clinical Monitoring - Clinical Research - Clinical Trial Protocol - Decision Making Skills - Drug Development - Health Sciences - Life sciences - Medical Strategy - Regulatory Compliance Language: - English Novartis offers a collaborative environment where passionate individuals can work together to achieve breakthroughs that positively impact patients" lives. For those interested in joining the Novartis Network, opportunities can be explored through the talent community to stay connected with suitable career options. Additionally, Novartis provides benefits and rewards to support personal and professional growth. Novartis is dedicated to fostering an inclusive work environment that represents the diversity of the patients and communities served. Accommodations for individuals with disabilities are available upon request to ensure equal opportunities during the recruitment process or job performance.,

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: R&D Operations Job Sub Function: Clinical Trial Support Job Category: Professional All Job Posting Locations: Mumbai, India, PENJERLA, Telangana, India Job Description: A Senior, Site Manager is a mid-level site management role with typically 3-5 years of clinical monitoring experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. A Senior, Site Manager is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The Senior, Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols. A Senior, Site Manager may contribute to process improvement, training and mentoring of other Site Managers. A Senior, Site Manager is generally expected to be able to operate independently with little or limited supervision. Assists throughout the start-up, execution, and completion of clinical research studies, ensuring the safety and confidentiality of all study subjects. Documents site visits, investigational product assessments, and other relevant observations and identifies opportunities to improve outcomes. Acts as a point of contact for the clinical trial team and escalates issues to appropriate trial leaders. Gathers data on the clinical trial environment and measures against key performance indicators. Observes and trains patients on trial purpose and outcomes in accordance within all regulatory requirements, under general supervision. Maintains records and documentation of safety related events. Coaches more junior colleagues in techniques, processes, and responsibilities. Understands and applies Johnson & Johnson s Credo and Leadership Imperatives in day-to-day interactions with team.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional All Job Posting Locations: Mumbai, India Job Description: A Senior, Local Trial Manager is a mid-level trial management role with typically at least 2 years of clinical trial management or atleast 6-8 years of clinical monitoring experience. This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The Senior, Local Trial Manager is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. The Senior, Local Trial Manager is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Senior, Local Trial Manager actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and Associate, Local Trial Managers. The Senior, Local Trial Manager may have some site management responsibilities. Configures systems to facilitate the operations of clinical trial phases to ensure staff are able to complete testing and analysis in a timely and effective manner. Analyzes standard operating procedures for clinical trial project management to ensure current methods are optimized and determine methods of improvement. Documents findings and events throughout the duration of a clinical trial project to present findings to leadership and ascertain organizational trends. Incorporates relevant modern advances in the field into clinical research to ensure the company stays up-to-date on the current knowledge and practices of the field. Edits and writes draft presentations and manuscripts for clients and stakeholders. Communicates with stakeholders and site staff on relevant discoveries or issues to ensure all involved parties are informed of project affairs. Coaches more junior colleagues in techniques, processes and responsibilities. Understands and applies Johnson & Johnson s Credo and Leadership Imperatives in day-to-day interactions with team.