Clinical Operations Manager
EPM Scientific are currently working with a growing, small biotech Company with an exciting specialized pipeline urgently seeking a Clinical Manager to join their team. See a short summary below; Contract Conditions: Start date: As soon as possible Location: Europe (Remote) Interviews: As soon as possible Language: English, additional European Languages are a plus Project: Neurology, Rare Disease Key Responsibilities: - Establishing and managing timelines, budgets, and resource plans for clinical trials. - Coordinating and leading cross-functional teams, including investigators, CRAs, lead CRAs, and site coordinators. - Ensuring precision in documentation, data entry, and adherence to regulatory standards. - Fostering a collaborative and high-performing team environment. - Addressing and resolving operational challenges during trial execution. - Navigating unexpected issues while preserving the integrity of the study. - Supervising CROs, laboratories, and other external vendors. - Overseeing site selection, initiation, and ongoing monitoring activities. Requirements: - Strong experience (8-12 years) in Clinical Operations / Development within the biotech or - pharmaceutical industry. - Experience in CNS studies is a plus. - Exceptional written and verbal communication skills. - Strong leadership and organizational skills, with a collaborative approach to teamwork. If this role is of interest to you, please apply directly to learn more about the role. If not feel free to share with your network.
Negotiable
France
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Clinical Research Associate
Clinical Research Associate San Diego, California (Hybrid) Compensation: $100,000-125,000 + Bonus + Equity Company Summary: We are partnered with an Cell Therapy focused company looking to revolutionize the way we approach cell therapy within Oncology & Autoimmune diseases. Their proprietary approach will dramatically cut time and cost associated with other cell therapy treatments like CAR-T. Their leadership team is equally exciting as their science with their CEO and CMO successfully raising hundreds of millions in funding at other organizations while gaining successful approvals. Their strong leadership has also led to a successful IPO for this organization earlier this year. If interested in learning more don't hesitate to apply. Primary Responsibilities: Organizes and supports trial managers in conducting all study team meetings, including agenda and meeting minute preparation, completion, and distribution. Manages the review of Site Essential Documents during study start-up, maintenance, and close-out. Supports the preparation and maintenance of regulatory and study-specific documentation (e.g., consent forms, site instructions, study-specific materials such as the Manual of Operations, Pharmacy binder, etc.). Ensures tracking and filing of essential documents in the appropriate tracking systems. Tracks patient status throughout the study at investigative sites. Maintains internal tracking systems of patient and site status to support trial and management needs. May review and approve trip reports, track data query reports, site visit metrics, and overall site performance. May perform site initiation, routine monitoring, and close-out visits at a limited number of clinical sites, as well as co-monitoring with local CRAs. Ensures the quality of data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues. May assist in the preparation of and present at investigator vendor meetings and workshops. Actively involved in performing study feasibility assessments. Provides rapid action to address both internal and site QA findings from audits. Coordinates the activities of third-party vendors, including metrics, accruals, process planning, and implementation. Routinely participates in department and clinical trial team meetings and collaborative efforts (e.g., protocol development, CRO selection, departmental initiatives, etc.). Supports CTM with oversight of TMF completeness, timeliness, and quality of filed documents. Qualifications: 2+ years clinical operations experience in a biotech, pharma, or CRO company. Experience working at the site level. .
US$100000 - US$130000 per year
La Jolla
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Sr. Clinical Trial Manager - EMEA
Sr. Clinical Trial Manager - EMEA Greater NYC Area (Hybrid) Compensation: $160,000-182,000 + Bonus + Equity Company Summary: We are partnered with one of the hottest biotech's around at the moment that is growing its Clin Ops team ahead of a large phase 3 Oncology trial. This company is founded and led by some of the industries brightest with their C suite coming from the a big pharma company that got the first CAR-T product approved. 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. Primary Responsibilities: 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 successful in-house implementation and management of oncology clinical trials. Collaborate with cross-functional teams, including data management, clinical scientists, regulatory, and investigators, to ensure operational excellence and rapid delivery of high-quality data. Ability to examine functional issues from a broader organizational perspective. Manage all aspects of trial start-up activities, collaborating with other Clinical Operations functions (Site Engagement & Monitoring Excellence, and Supplier Relationship Management & Performance) to deliver efficient and effective site selection, feasibility assessments, and preparation of study-related documentation. Collaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to efficiently and effectively deliver study site initiation, training, and monitoring activities to ensure adherence to study protocols, regulatory requirements, and ICH-GCP guidelines. Develop and maintain strong relationships with investigators, study coordinators, and study site personnel to facilitate patient recruitment and retention. Monitor and evaluate study progress, identifying risks, issues, and deviations, and implement appropriate corrective actions to maintain study integrity and timelines. Ensure compliance with regulatory requirements, including ICH-GCP, FDA guidelines, and other applicable regulations throughout the trial lifecycle. Collaborate with external vendors, including CROs, central laboratories, and imaging providers, to ensure their efficient and effective deliverables to the trial. Contribute to the development and review of study-related documents, such as protocols, informed consent forms, case report forms (CRFs), and standard operating procedures (SOPs). Prepare study materials and establish procedures to ensure adherence to study protocols and administrative requirements. Lead the creation and maintenance of all study files, including the study master file, and oversight of site files. Lead periodic review of the Sponsor Trial Master File. Qualifications: 5+ years clinical operations experience. Experience in oncology Ability to speak a European Language
US$160000 - US$182000 per year
Jersey City
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Clinical Research Associate (Clinical Specialist)
Salary: $95-115K Company Summary: A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Clinical Research Associate for a hybrid role at their San Francisco site. Their commercial supply of pharmaceutical products generated $83m in revenue in FY2023 (a 24% uptick from the year prior). Since their first clinical trials in 2006, they've had 3 approvals already on the market. Currently, they have 6 indications in Phases II and III, so they are looking for a driven, growth-oriented Clinical Research Associate to facilitate their in house studies. The CRA will be responsible for: Managing and investigating clinical trials and/or post-authorization safety studies Performing and coordinating different aspects of clinical monitoring and site management 50-75% travel An ideal candidate for this role MUST haveโฆ 2+ years of ONSITE monitoring experience at a sponsor or CRO A Bachelor's degree in Biological Sciences, Nursing, Pharmacy or a related discipline A working knowledge of ICH GCP guidelines Benefits: Competitive salary with benefits High degree of commercial exposure early in your career Being a part of team whose work directly aims to improve the quality of people's lives Great work-life balance If you are interested in this Clinical Research Associate role, don't hesitate to reach out!
US$95000 - US$115000 per year
San Francisco
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Associate Director of Clinical Operations
Associate Director of Clinical Operations San Diego, CA - Hybrid $150,000 - $1800,000 A clinical-stage biotechnology company in San Diego is dedicated to developing transformative medicines for patients with life-threatening diseases. This company focuses on precision medicine, leveraging advanced technologies to create innovative therapies that address significant unmet medical needs. With a robust pipeline targeting various cancer types and other serious conditions, the company is at the forefront of developing next-generation treatments. Supported by a strong leadership team with extensive industry experience and significant funding from top-tier investors, the company is well-positioned for rapid growth and success in the biotech industry. Joining this team means being part of a passionate group committed to making a tangible difference in patients' lives. Responsibilities: Oversee the planning, execution, and management of clinical trials, ensuring compliance with regulatory requirements and company standards Manage relationships with CROs and other vendors, including contract negotiations and performance monitoring Provide direction and support to clinical operations team members, fostering a collaborative and high-performance environment Ensure all clinical activities adhere to GCP, FDA, and other regulatory guidelines Develop and manage clinical trial budgets, ensuring cost-effective use of resources Identify potential risks and implement mitigation strategies to ensure the successful completion of clinical trials Ensure the accuracy and integrity of clinical trial data through rigorous monitoring and quality control processes Work closely with other departments, including clinical development, regulatory affairs, and data management, to achieve project goals Oversee the preparation and review of clinical trial documentation, including protocols, informed consent forms, and study reports Identify opportunities for process improvements and implement best practices in clinical operations Qualifications Bachelor's degree in a scientific or health-related field. At least 2 years of experience in clinical research, ideally within a biopharmaceutical or CRO setting. Knowledge of FDA regulations and ICH/GCP guidelines is essential. Strong organizational and multitasking skills, with the ability to work in a collaborative team environment. Excellent written and verbal communication skills. Problem-solving and negotiation abilities, with the ability to adapt as needed. Proficiency in Microsoft Office and experience with clinical trial management systems (e.g., Medidata Rave, InForm). This role offers the opportunity to contribute to groundbreaking therapies in a dynamic and innovative environment. If you are passionate about clinical operations and making a difference in patients' lives, we encourage you to apply.
US$150000 - US$180000 per year
San Diego
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Senior Clinical Reseach Associate
A leading biotech company is on the lookout for a Senior Clinical Research Associate to support their clinical operations team. This innovative company is at the forefront of developing therapies that address critical unmet medical needs, with a strong focus on rare diseases. By joining this team, you will be instrumental in advancing pioneering treatments that have the potential to revolutionize patient care. The leadership team comprises seasoned industry experts with a wealth of experience in drug development and commercialization. They have a proven track record of successfully guiding multiple programs from early development stages through to regulatory approval and market launch. With a robust pipeline of promising candidates, the company is strategically positioned for sustained growth and success in the biotech industry. Responsibilities: Manage clinical trial activities to ensure studies are completed on time, within budget, and in compliance with regulatory standards. Oversee trial aspects, including study start-up, patient enrollment, site interactions, and data management. Draft and review key study documents, such as informed consent forms and case report forms. Select and manage study sites, evaluate CROs and other service providers, and oversee contracts and budgets. Provide study updates to cross-functional teams and address issues with sites and CROs. Conduct site visits, including qualification, initiation, monitoring, and close-out visits. Support internal and external audits, addressing and resolving any findings. Qualifications and Experience: Bachelor's degree in a scientific or health-related field. At least 3 years of experience in clinical research, ideally within a biopharmaceutical or CRO setting. Experience with rare disease trials is highly preferred; early-phase development experience is beneficial. Knowledge of FDA regulations and ICH/GCP guidelines. Strong organizational and multitasking skills, with the ability to work in a collaborative team environment. Excellent written and verbal communication skills. Proficiency in Microsoft Office and experience with clinical trial management systems (e.g., Medidata Rave, InForm). If you are interested, plase dont hestitate to apply.
US$90000 - US$120000 per year
San Diego
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Clinical Trial Director
Job Title: Clinical Trial Director Location: Boston, Massachusetts Salary: $180,000-$220,000 Job Summary: The Clinical Trial Director will lead and oversee all clinical trial activities for their lead asset focused in radiopharmaceuticals. This role is critical in ensuring the successful execution of clinical trials, from early-phase studies through to late-stage development. It is also critical in the company's expansion into the US and overseeing their new US sites. The director will report to the Head of Development. Key Responsibilities: Develop and implement clinical operations strategies to support the company's oncology radiopharmaceutical pipeline. Provide leadership and direction to the clinical operations team, ensuring alignment with corporate goals and objectives. Oversee the planning, execution, and management of clinical trials, ensuring they are conducted in compliance with regulatory requirements and Good Clinical Practice (GCP). Manage all aspects of clinical trials, including site selection, patient recruitment, data collection, and monitoring. Ensure timely and accurate reporting of trial progress and results to senior management and stakeholders. Develop and manage clinical trial budgets, timelines, and resources. Ensure all clinical trial activities are conducted in accordance with regulatory requirements and company SOPs. Prepare and submit regulatory documents to ethics committees and regulatory authorities. Lead, mentor, and develop the clinical operations team, fostering a collaborative and high-performance culture. Provide training and support to team members to ensure continuous professional development. Collaborate with cross-functional teams, including clinical research, regulatory affairs, data management, and biostatistics, to ensure the successful execution of clinical trials. Act as a key liaison between the clinical operations team and other departments within the company. Qualifications: Minimum of 10 years of experience in clinical trial management, with at least 5 years in a leadership role. Minimum 7 years of experience in biotech on the sponsor side. Excellent organizational, communication, and leadership skills. Proven ability to manage multiple projects and priorities simultaneously. Preferred Qualifications: Experience in early-phase oncology trials. Radiopharmaceutical experience.
US$180000 - US$220000 per year
Boston
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Associate Director Clinical Operations - Centralized Monitoring
Associate Director Clinical Operations - Centralized Monitoring Remote (Must be based in MD, NC, VA, DC) $135,000-$175,000 Job Description EPM is partnered with a leading Contract Research Organization (CRO) dedicated to advancing clinical research and improving patient outcomes. Our partner is renowned for its innovative approach, cutting-edge technology, and commitment to excellence in clinical trials. With a global presence and a diverse portfolio of therapeutic areas, they offer a dynamic and collaborative environment for professionals passionate about making a difference in healthcare. Join a team that values integrity, innovation, and impact, and be part of a mission to transform clinical research. Key Qualifications Bachelor's degree in Life Sciences, Nursing, or a related field; advanced degree preferred. Minimum of 8 years of experience in clinical operations, with at least 3 years in a leadership role. Proven experience in central monitoring and remote data review. Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements. Excellent leadership, communication, and interpersonal skills. Ability to manage multiple projects and priorities in a fast-paced environment. Experience with budget management and resource allocation. Proficiency in clinical trial management systems (CTMS) and other relevant software. Key Responsibilities: Oversee the planning, execution, and management of clinical trials. Lead and mentor a team of clinical operations professionals. Ensure compliance with GCP, regulatory requirements, and company SOPs. Collaborate with cross-functional teams to achieve project goals. Manage budgets, timelines, and resources effectively. Build and develop a team of CTM's and CRA's to monitor clinical trials Establish Risk-Based Quality Management and Centralized Monitoring processes corporately and for applicable clinical trials. Review protocols to ensure the set-up, review and reporting requirements for KRIs and QTLs can be met and are standardized. Provide technical oversight, guidance and coordination for all the central monitor activities. Perform central monitoring activities including review system outputs, propose suggestions for signal and action management, and follow up with study team for action resolutions. Benefits Medical Dental Vision PTO
US$135000 - US$175000 per year
Bethesda
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