Director Clinical Affairs
Director Clinical Affairs Salary: ($220,000-$250,000) Remote, USA EPM is partnered with a leading medical device organization in the Diagnostics Solutions space. This publicly traded company have several portfolios, and are seeking a Director Clinical Affairs to run one of the largest DS teams on the planet. This is a high exposure role to the senior executive team, and is a great opportunity to take part in helping the lives of millions of patients, worldwide. Responsibilities: Lead the development of clinical strategy, trial design, and sucessful execution of clinical studies Work cross functionally with medical affairs, data management, quality, and biostats Oversee budgets and contracts The ideal candidate for this role will have: Bachelor's Degree required, 10+ years experience leading diagnostics solutions clinical affairs teams 10+ years experience on the industry side This company offers a competitive compensation package: Annual bonus Equity package 401(k) match program Health, Vision, Dental, Life Insurance Please apply now!
US$220000 - US$250000 per year
United States of America
Apply
Sr. Clinical Trial Manager - EMEA
Sr. Clinical Trial Manager EMEA New York City, NY Compensation: $162,000-180,000 Company Summary: A newly established biopharmaceutical company is leveraging cutting-edge technology at the intersection of chemistry, engineering, computation, and biology to discover innovative treatments for life-threatening diseases. Primary Responsibilities: In collaboration with a clinical study management partner, provide guidance and daily oversight for the successful in-house management of all aspects of international clinical trials, ensuring high-quality study data is delivered on time and within budget. Develop and execute operational plans for the effective in-house implementation and management of oncology clinical trials. Work with cross-functional teams, including data management, clinical scientists, regulatory personnel, and investigators, to ensure operational excellence and the rapid delivery of high-quality data. Qualifications: Comprehensive understanding of clinical trial regulations, guidelines, and best practices relevant to specialized research. Fluent in Russia, Spanish, French, German, Spanish, or any other European languages Proven experience in overseeing and executing Phase 3 clinical trials. Strong background in Oncology In sourced experience or FSP model in CRO
US$160000 - US$182000 per year
Hayward
Apply
Clinical Trial Manager
Clinical Trial Manager San Francisco Bay Area Salary: $130,000-$170,000 +15% bonus + pre-IPO equity This company is founded and led by some of the industries brightest with their C suite coming from the likes of Merck. Much of their leadership were crucial to the development of Keytruda. This company is one that has potential well beyond just one blockbuster drug due to their proprietary drug discovery platform. This platform is rooted in a new way to characterize protein that has led them to much more accurate drug targets. What makes this exciting is that it not only has applications in Oncology, but Neurology and Immunology as well. With nearly $800 million in funding they have a cash runway for years to come, and their current pipeline is robust. In addition to the phase 3 you will be working on they have 11 other indication in development. The Clinical Trial Manager will be responsible for: Collaborate with external vendors, including CROs, laboratories, and imaging providers, to ensure timely and effective deliverables. Build and maintain strong relationships with investigators, study coordinators, and site personnel to support patient recruitment and retention. Monitor and assess trial progress, identify risks, and implement corrective measures to achieve study goals and maintain timelines. Ensure regulatory compliance with FDA guidelines, ICH-GCP standards, and other relevant regulations. Oversee all aspects of global clinical trial management, ensuring high-quality study data is delivered on time and within budget. Lead trial start-up activities, collaborating with Clinical Operations teams for site selection, feasibility assessments, and documentation. Develop and execute operational strategies for the management of oncology clinical trials. Support site initiation, training, and monitoring to guarantee compliance with protocols, regulatory standards, and ICH-GCP guidelines. Collaborate with cross-functional teams, including data management, clinical scientists, regulatory groups, and investigators, to uphold operational excellence. Contribute to the creation and review of key study documents such as protocols, informed consent forms, case report forms (CRFs), and standard operating procedures (SOPs). Maintain detailed study files, including the study master file and site file oversight, and conduct regular reviews. The Clinical Trial Manager should have the following qualifications: In-depth knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements, specific to oncology research Demonstrated experience in managing and executing clinical trials from start-up to closeout Proficiency in using Veeva clinical trial management systems (CTMS) Understanding of oncology therapeutic areas, including familiarity with oncology treatment modalities, disease progression, and related medical terminology. Benefits: A competitive salary with benefits. A real hands-on opportunity to gain a high degree of commercial exposure. Working with highly-talented and dedicated colleagues in a fast-growing company that combines a focus on cutting-edge science with commercial delivery If you are interested in the Clinical Trial Manager role, then please don't wait to apply.
US$140000 - US$160000 per year
San Francisco
Apply
Clinical Trial Manager
Clinical Trial Manager New York City, NY Compensation: $140,000-160,000 Company Summary: A newly established biopharmaceutical company is leveraging cutting-edge technology at the intersection of chemistry, engineering, computation, and biology to discover innovative treatments for life-threatening diseases. Primary Responsibilities: In collaboration with a clinical study management partner, provide guidance and daily oversight for the successful in-house management of all aspects of international clinical trials, ensuring high-quality study data is delivered on time and within budget. Develop and execute operational plans for the effective in-house implementation and management of oncology clinical trials. Work with cross-functional teams, including data management, clinical scientists, regulatory personnel, and investigators, to ensure operational excellence and the rapid delivery of high-quality data. Qualifications: Comprehensive understanding of clinical trial regulations, guidelines, and best practices relevant to specialized research. Proven experience in overseeing and executing Phase 3 clinical trials. Strong background in Oncology In sourced experience or FSP model in CRO
US$140000 - US$160000 per year
New York
Apply
CTM
Job Title: Clinical Trial Manager Location: San Francisco Bay Area Compensation: $140k-$170k Description: We are partnered with an innovative Oncology-focused Biotechnology company that is looking for their next CTM. A newer company on the scene that is offering an innovative approach to their upcoming trials, with strong leadership who have gotten other products approved previously. This is your opportunity to join a cutting-edge company with high potential at the ground floor. Position Overview: The CTM role will primarily be responsible for overseeing trial monitoring, designing and enforcing trial protocols and compiling data for presentation purposes. The ideal candidate has direct leadership experience within clinical trials. It is of the utmost importance that this candidate ensures that company and regulatory standards are upheld while efficiency is maintained. Key Responsibilities: Lead the planning and execution of clinical trials from start to finish. Develop and manage trial budgets, timelines, and resources. Ensure compliance with all regulatory requirements. Oversee the selection and management of clinical trial sites and vendors. Collaborate with cross-functional teams, including clinical operations, data management, biostatistics, and regulatory affairs. Monitor trial progress and implement corrective actions as needed. Prepare and present trial updates to senior management and stakeholders. Mentor and train junior staff members. Qualifications: Bachelor's degree in life sciences, nursing, or a related field (advanced degree preferred). Minimum of 7 years of experience in clinical trial management, with at least 3 years in a senior or lead role. In-depth knowledge of clinical trial processes, regulations, and best practices. Strong leadership and project management skills. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Proficiency in clinical trial management software and tools. Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. 401(k) with company match. Generous paid time off and holidays. Professional development opportunities. A collaborative and supportive work environment.
US$140000 - US$170000 per year
San Francisco
Apply
Clinical Specialist
Job Title: Clinical Specialist - Ophthalmology Location: Nordics (Denmark, Sweden, Norway, Finland) Industry: Medical Devices - Ophthalmology Employment Type: Full-Time About the Company: Our client is a global leader in ophthalmic technologies, offering cutting-edge solutions in surgical devices, diagnostics, and vision care. With a strong commitment to innovation and clinical excellence, they are dedicated to improving visual outcomes and patient quality of life across the globe. The Role: As a Clinical Specialist, you will play a key role in supporting ophthalmic surgeons and clinical teams across the Nordics. You will provide expert training, in-theatre support, and ongoing education to ensure optimal use of advanced ophthalmology products, including surgical systems and diagnostic platforms. Key Responsibilities: Deliver high-quality clinical training and product support to surgeons, nurses, and clinical staff Provide in-theatre assistance during procedures, ensuring correct use and best practices Partner with the sales team to support product evaluations, demonstrations, and post-sale adoption Act as a key point of contact for clinical feedback and continuous education Stay updated on clinical trends, market developments, and competitor activities across the region About You: Background as a nurse, orthoptist, optometrist, or similar clinical role in ophthalmology Strong knowledge of ophthalmic procedures and products, particularly surgical and diagnostic technologies Excellent communication and interpersonal skills with a customer-centric mindset Willingness to travel extensively across the Nordic region (up to 70%) Fluent in English and at least one Nordic language (Swedish, Danish, Norwegian, or Finnish) What's on Offer: Competitive salary and bonus structure Company car or travel allowance Structured onboarding and continuous clinical training Opportunity to work with industry-leading technology in a growing and supportive team Clear development pathway into senior clinical or commercial roles How to Apply: If you're a clinically driven professional passionate about advancing ophthalmic care, apply today.
Negotiable
Norway
Apply
Sr. Clinical Trial Manager
Clinical Trial Manager Jersey City, New Jersey or New York City (Hybrid) $140,000 - $160,000 Job Description Founded by a team of noble prize winning scientists, EPM is partnered with one of the most exciting and cutting edge biotech companies in the industry. They have raised over $1 billion dollars of funding to advance their pipeline of 7 programs and are gearing up for their first Phase 3. Focusing in oncology, they are using a first of it's kind drug discovery platform that has allowed them to create the most innovative drugs ever seen. Key Qualifications Proven track record with a significant duration of experience working specifically in the field of Oncology within the pharmaceutical or biotech industry. In-depth knowledge of Oncology clinical trials, including protocol design, patient recruitment, and monitoring, with a demonstrated ability to navigate the unique challenges associated with neurological disorders. Comprehensive understanding of regulatory requirements and guidelines, ensuring compliance with regulatory standards throughout the drug development process. Substantial experience in managing investigational sites, building and maintaining effective relationships, and optimizing site performance to ensure successful trial execution. Proficiency in overseeing data review processes, including source data verification and analysis, to ensure the accuracy and integrity of clinical trial data in the autoimmune therapeutic area. Roles & Responsibilities Lead and oversee the planning, initiation, and execution of clinical trials, ensuring adherence to protocols, regulatory requirements, and ethical standards. Effectively manage relationships with investigational sites, fostering collaboration, providing support, and addressing site-specific needs to optimize site performance throughout the trial. Implement robust data monitoring processes, conducting regular reviews and source data verification to ensure the accuracy and integrity of data collected in clinical trials. Ensure all aspects of clinical trials comply with relevant regulatory requirements and guidelines, collaborating with regulatory affairs to address any compliance-related issues and facilitate successful trial outcomes. Proactively identify potential risks associated with Oncology trials and develop strategic plans for risk mitigation. Address and resolve issues promptly to ensure the smooth progression of the trial and meet project timelines. Benefits Medical, dental, vision insurance 401(k) PTO and Holidays
US$140000 - US$160000 per year
San Francisco
Apply
Senior Clinical Project Manager
Senior Clinical Project Manager San Diego, CA - Hybrid $120,000 - $160,000 An ADC focused biotech in San Diego is currently building out their Clinical Operations team to support their innovative pipeline with therapies ranging from Phase 1-3. As I'm sure you are well aware, ADC's are seen as the future of how we will tackle Cancer in an innovative yet more plausible way compared to other less scalable treatments like Cell Therapy that is still decades away of being accessible to the average cancer patient. The Clinical Project Manager will provide operational expertise within the Research and Development function to ensure timely initiation, execution, and reporting of clinical trials in accordance with ICH/GCP and all applicable requirements (including local regulations) to support licensure of products in the United States and global markets. This role will work closely and collaboratively with Program Management, Data Management, Clinical Development, Medical Writing, Biostatistics, Clinical Supply, Global Medical Safety, GCP Quality, and Regulatory staff as well as Clinical Research Organizations, to ensure the timely execution of studies within budget. Emphasis will be on superior execution, transparency within the department and to Senior Management, and the ability to employ cost-effective measures and stewardship relative to clinical trial cost projections and final accounting. Responsibilities (including, but not limited to) Independently managing all operational aspects for implementation of clinical trial activities from study start-up through database lock, with expertise in accelerating project launch and site start-up/activations, while ensuring adherence to protocol, GCPs, and relevant SOPs. Leading internal cross-functional study teams and partnering with CROs to ensure effective and timely communication, study execution in accordance with the timeline and budget. Actively participating in protocol design, CRO selection, site selection, and IRB/EC applications for early and late-phase clinical studies. Managing study-related vendors and serving as the primary point of contact for contracted CROs, study staff, and contract labs; identifying potential risks and proactively resolving issues with CROs; establishing vendor management plans and reviewing quality metrics. Performing and/or overseeing site monitoring visits for clinical trials as needed. Facilitating the timely completion of study protocols (including amendments) and development (and revision) of electronic clinical trial systems (e.g., EDC, IRT). Providing input into and/or developing study-related materials such as Clinical Monitoring Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, patient informed consent drafts, site instructions for specimen collections, and study drug order forms. Reviewing monitoring reports, protocol deviations, and data listings for sponsored studies to ensure reliable quality data are delivered. Coordinating with CROs on site selection, IRB submissions, site initiation, and close-out planning. Managing in a timely and efficient manner all operational aspects of protocol amendments. Developing and managing reports for communicating study progress and key metrics to Senior Management and program team. Coordinating the negotiation of site budgets within guidelines and providing oversight for site payments per contracts. Facilitating site study drug orders, and ensuring full drug chain record management, including site accountability records are maintained; managing non-drug supply ordering and tracking, as required. Providing oversight and ensuring maintenance of clinical trial master files to ensure their compliance with required regulatory and ICH/GCP quality standards and consistency with SOPs. Providing input to Drug (IND) filings, Clinical Trial Applications, safety reports, clinical study reports, and other ICH compliant sections of registration dossiers (e.g., BLA, MAA, NDA, etc.). Providing oversight of clinical trials to ensure that all adverse events or product safety issues are captured, reported, and evaluated by appropriate Clinical personnel in a timely manner. Establishing a system and procedure for forecasting (and reforecasting) needs for investigational product for each study and communicating those needs on a routine basis. Ensuring inspection readiness and participating with CROs and providing support to sites to prepare for clinical audits/inspections and to respond to audit/inspection findings conducted by internal QA and external regulatory agencies. Qualifications Requires a Bachelor's Degree in health or biologic science (BS/BA/BScN or higher); a master's-level degree is preferred. A minimum of 5 years of clinical operations experience at a sponsor or CRO, including 1 year as a clinical study lead/project manager is required; global clinical trial experience is required with cardiovascular, rare disease, and/or Phase 1 experience highly preferred. Solid, well-grounded experience in setup, execution, and operational management of domestic and international Phase 1, 2, and/or 3 clinical trials across an array of therapeutic areas, including expertise in all aspects of investigational site start-up. Effective project management and risk management skills. Excellent listening, communication (written, spoken), and interpersonal skills; ability to foster team spirit.
US$120000 - US$160000 per year
San Diego
Apply
Director, Trial Master File (TMF) Operations
Job Type: Full-time Salary: $200K-$215K Location: San Francisco Bay Area Company Summary: A pre-IPO clinical stage biotech developing therapies to treat cancer and autoimmune disease. Currently they are backed by VCs and have successfully raised nearly a $1 billion continue advancing their clinical programs. The Opportunity: The Director, TMF Operations will lead TMF operations for all of the clinical trials across the organization. You will need to drive change and progress at a strategic level, and will therefore, need to possess the necessary communication and collaboration skills to ensure TMFs are complete, accurate, and compliant with regulations. Responsibilities: Leading the TMF Operations function to support Clinical Research and Development Managing and overseeing the TMF Operations team, including hiring, training, and performance management Maintaining strong relationships with TMF third party vendors, including driving resolution of issues and remediation activities Develop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices Develop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirements Collaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival Develop and establish TMF Key Performance Indicators (KPIs) globally for internal staff, CRO, and other stakeholders An ideal candidate for this role MUST haveโฆ Minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree Proven leadership experience in an insourced biotech organization Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations Experience with electronic Trial Master File systems (e.g., Veeva) and related technology platforms Benefits: Pre-IPO biotech company Competitive salary with comprehensive benefits (100% medical coverage) 401K contribution
US$200000 - US$215000 per year
Millbrae
Apply
Sr. Clinical Trial Manager - EMEA
Sr. Clinical Trial Manager EMEA New York City, NY Compensation: $162,000-180,000 Company Summary: A newly established biopharmaceutical company is leveraging cutting-edge technology at the intersection of chemistry, engineering, computation, and biology to discover innovative treatments for life-threatening diseases. Primary Responsibilities: In collaboration with a clinical study management partner, provide guidance and daily oversight for the successful in-house management of all aspects of international clinical trials, ensuring high-quality study data is delivered on time and within budget. Develop and execute operational plans for the effective in-house implementation and management of oncology clinical trials. Work with cross-functional teams, including data management, clinical scientists, regulatory personnel, and investigators, to ensure operational excellence and the rapid delivery of high-quality data. Qualifications: Comprehensive understanding of clinical trial regulations, guidelines, and best practices relevant to specialized research. Fluent in Russia, Spanish, French, German, Spanish, or any other European languages Proven experience in overseeing and executing Phase 3 clinical trials. Strong background in Oncology In sourced experience or FSP model in CRO
US$160000 - US$182000 per year
Hayward
Apply
Clinical Trial Manager
Clinical Trial Manager New York City, NY Compensation: $140,000-160,000 Company Summary: A newly established biopharmaceutical company is leveraging cutting-edge technology at the intersection of chemistry, engineering, computation, and biology to discover innovative treatments for life-threatening diseases. Primary Responsibilities: In collaboration with a clinical study management partner, provide guidance and daily oversight for the successful in-house management of all aspects of international clinical trials, ensuring high-quality study data is delivered on time and within budget. Develop and execute operational plans for the effective in-house implementation and management of oncology clinical trials. Work with cross-functional teams, including data management, clinical scientists, regulatory personnel, and investigators, to ensure operational excellence and the rapid delivery of high-quality data. Qualifications: Comprehensive understanding of clinical trial regulations, guidelines, and best practices relevant to specialized research. Proven experience in overseeing and executing Phase 3 clinical trials. Strong background in Oncology In sourced experience or FSP model in CRO
US$140000 - US$160000 per year
New York
Apply
