Junior Partner/Partner, Real World Solutions
OPEN TO RELOCATING CANDIDATES Location: South Korea, Seoul Our client is a leading consultancy firm seeking to hire an experienced and dedicated Real World Evidence Junior Partner for their operations in Korea. The successful candidate will have the opportunity to work with top-tier clients, utilizing their expertise and knowledge of RWE to drive business growth. Responsibilities: Primary overseer of client engagements with utmost responsibility for ensuring client satisfaction and delivering superior levels of quality and added value. Achieves or surpasses designated revenue targets by crafting and delivering insightful, value-added solutions that tackle intricate client challenges. Actively seeks out and pinpoints new revenue prospects within existing and potential client bases, ensuring a consistent influx of business from client engagements. Acts as a solutions-focused expert, both internally and externally, utilizing consultative problem-solving skills. Develops and delivers insightful, value-added strategies for addressing complex client issues. Generates and expands new business opportunities by identifying value-added follow-on work and pinpointing new revenue prospects within existing and new client organizations. Qualifications: Proven track record of delivering projects related to real world evidence (RWE) Bachelor's Degree required, advanced Degree preferred. At least 15 years of experience in the life science or consulting industry Proven track record of delivering projects related to real world evidence (RWE) and HEOR related projects Business Development skills and sales experience; Excellent communication skills Billingual If you are interested, please apply with your CV attached.
Negotiable
United States of America
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Field Application Specialist
Are you a professional Field Application Specialist with experience supporting surgeons and medical staff in live environments, providing on site technical support, and conducting educational training? If you're passionate about innovative ophthalmology equipment and ready to assist health care professionals in real-time settings, this Field Application Specialist role in South Central/South West UK may be perfect for you. Key Responsibilities: Conduct training for end users, such as surgeons and nursing teams, to ensure safe and efficient use of specialised surgical equipment. Support installation and provide hands-on demonstrations of surgical devices and equipment to medical staff, identifying opportunities for cross-promotion. Deliver technical assistance, field repairs, and maintenance for equipment, promptly resolving first-line technical issues. Stay informed about the latest instruments, disposables, and surgical techniques to confidently introduce new products to clients. Required Skills and Experience: Minimum of 3 year's experience in Medical Sales or Field Applications. Background in Ophthalmology is an advantage. Bachelor's Degree preferred. Willingness to travel up to 20% within the region. Strong communication skills, self-driven, and capable of independent work. Service-oriented with familiarity in operating theatre protocols. Excellent verbal and written English skills. Effective in training and presenting to diverse audiences. Team player with a commitment to meeting client needs. Are you ready to join an innovative, forward-thinking organisation focused on advancing medical technology that makes a difference in patient lives? Apply Now!
Negotiable
England
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Clinical Trial Manager/Senior Manager
Location: Seoul, Korea Therapeutic Areas: Cardiovascular, Infectious Disease, CNS/Neuroscience An award-winning global Clinical Research Organisation with international reputation in providing Phase 1 to Phase IV clinical development services is looking for a Clinical Trial Manager to be based in South Korea. This opportunity provides amazing growth potential, career progression and the chance to be working with a growing company. Responsibilities: Lead projects for multi-service global clinical trials Manage project timelines and deliverables Lead cross functional teams - clinical monitoring, study start-up, regulatory, contract, safety, medical monitoring. Secure new businesses Requirements: Bachelor's degree (Masters or PhD preferred) Relevant experience in clinical trial management in Asia, in a CRO is preferred Preferably a tertiary education in law and/or experience within the Chinese legal jurisdiction Good communication skills and team spirit If you are interested, please apply with your CV attached.
Negotiable
Seoul
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Sr. Clinical Trial Manager
Salary: $160 - $180K Location: South San Francisco, CA (Hybrid - must be local) Company Summary: Working with the C-suite of a precision IO biotechnology company to build out their clinical operations team in an effort to develop best-in-class immunotherapies to address unmet needs within the oncology space. Their pipeline consists of 1 Phase Ib asset and 4 more preclinical assets. They are looking for a Sr. Clinical Trial Manager to join the team on a full-time basis. Responsibilities: Managing all clinical operational aspects of a global clinical trial including start-up, conduct and close out activities. Identifying potential study issues/risks and recommends/implements solutions. Managing CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project files) and serves as the primary CRO/vendor contact. Contributing to the writing, review and finalization of protocols or components of clinical study reports. Organizing clinical operational meetings. Developing and maintaining strong working relationships with principal investigators, key clinical opinion leaders and sites. May be responsible for contributing to development of RFPs and participates in selection of CROs/vendors as well as review of any CRO budgets and /or change orders. Developing strong cross-functional relationships and exhibits leadership skills with counterparts to ensure efficient execution of clinical trial. Ensuring adherence with SOP, applicable regulations, GCP, and ICH guidelines. Contributes to the development and/or review of study plans, ICFs, site manuals, patient materials, CRF completion guidelines, etc. Attend and/or present at Investigator Meetings as needed. Requirements: At least 8 years of industry (must be at a sponsor) experience REQUIRED 5-8 years of oncology trial management experience Global trial experience preferred A Bachelor's degree in Biological Sciences, Nursing, Pharmacy or a related discipline A working knowledge of ICH GCP guidelines Benefits: Pre-IPO biotech company Competitive salary with comprehensive benefits (90% medical coverage) Flexible PTO and WFH arrangements 401K contribution Cell phone reimbursement, life insurance, and additional perks
US$160000 - US$180000 per year
South San Francisco
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Clinical Trial Manager/Senior Manager
Location: Seoul, Korea Therapeutic Areas: Cardiovascular, Infectious Disease, CNS/Neuroscience An award-winning global Clinical Research Organisation with international reputation in providing Phase 1 to Phase IV clinical development services is looking for a Clinical Trial Manager to be based in South Korea. This opportunity provides amazing growth potential, career progression and the chance to be working with a growing company. Responsibilities: Lead projects for multi-service global clinical trials Manage project timelines and deliverables Lead cross functional teams - clinical monitoring, study start-up, regulatory, contract, safety, medical monitoring. Secure new businesses Requirements: Bachelor's degree (Masters or PhD preferred) Relevant experience in clinical trial management in Asia, in a CRO is preferred Preferably a tertiary education in law and/or experience within the Chinese legal jurisdiction Good communication skills and team spirit If you are interested, please apply with your CV attached.
Negotiable
Seoul
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Associate CTM
Associate Clinical Trial Manager San Francisco Bay Area Salary: $120,000-$145,000 A well-funded Bay Area radio-pharma biotech company is looking to add on to their clinical operations team. This company is reimagining the future of cancer treatment through innovative radiotherapeutics, and you can contribute to transform the treatment of cancer entirely. They're developing a novel precision medicine approach aimed at transforming patient outcomes in oncology though a best-in-class radiotherapy that selectively destroys tumor cells while sparing healthy cells. The leadership team at this company is poised to make it a standout in radiotherapies. Their CEO has 20+ years in life sciences and most recently secured $500M in Series A funding for a precision neurology biotech. The CMO brings experience from some of the most successful pharmaceutical companies in the world. They've had their first IND submission this year, with 5 additional cancer targets in their pipeline. They have already raised $140 Million in funding, and are operating in the highly innovative radio-therapy space. Key Responsibilities Support the management of clinical trial activities to ensure studies are completed on time, within budget, and in compliance with regulatory standards, standard operating procedures (SOPs), and ICH/GCP guidelines. Help oversee essential trial aspects, including study start-up, patient enrollment, site interactions, and data management, proactively identifying and resolving issues. Draft and review key study documents, including informed consent forms, case report forms, study manuals, and other trial materials. Assist in selecting and managing study sites and evaluating CROs and other service providers, as well as overseeing contracts and budgets. Work towards project goals, managing timelines and deliverables to align with organizational objectives. Provide study updates to cross-functional teams and help address issues with sites and CROs through analysis and action planning. Contribute to the development of study tools and resources to enhance data quality and trial efficiency. Participate in training new team members on study processes as needed. Track study progress, maintain relevant metrics, and keep the team informed. Serve as a key point of contact for study sites, and participate in assessing and resolving any safety or patient care issues. Oversee and support contract and budget negotiations with clinical sites. Assist in planning and presenting at investigator and CRO training meetings. Conduct site visits as needed, including qualification, initiation, monitoring, and close-out visits; perform oversight visits to review and assess CRO activities. Support internal and external audits, helping to address and resolve any findings. Qualifications and Experience 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. Oncology trial experience is highly preferred; early-phase development experience is beneficial. 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).
US$120000 - US$145000 per year
San Francisco
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Senior Director of Clinical Operations
Senior Director of Clinical Operations Greater San Diego Area (Hybrid) Salary: 234,000- 265,000 + 30% bonus + equity Our client is a cutting-edge NK cell therapy powerhouse. Being one of the only companies producing over the counter cell therapy compounds, this role offers a unique and innovative opportunity to a candidate looking to join the team as a Senior Director of Clinical Operations. What is really exciting about their drug discovery platform is that it is applicable to oncology, autoimmune, as well as other therapeutic areas. Their innovative platforms come from having one the most highly touted leadership teams in the cell therapy space. Their CEO and CMO both worked at other cell therapy companies that have gained successful approvals before joining our client. With a robust pipeline; boasting several drugs in early phase trials, and one compound in phase three; this company is looking for an eager candidate willing to work in a fast-paced environment. This is a newly created position which allows for the right candidate to build and nurture a team at the forefront of cell therapy innovation. The Senior Director of Clinical Operations will be responsible for: Assess and deploy resources to execute corporate priorities Implement clinical trial plans considering time lines, budgets, and resources Develop and execute risk mitigation plans for compliant, timely, and cost-effective trials Manage RFP process for CROs and vendors, including evaluation and selection Oversee vendor agreements, ensuring adherence to scope, budgets, and time lines Evaluate and select clinical sites, engaging with staff to meet enrollment goals Drive operational excellence in clinical documentation and practices Review invoices for accuracy against plans, budgets, and study progress Prepare cost projections and budget forecasts with Finance Team Maintain productive relationships with CROs, vendors, and clinical sites Supervise Clinical Trial Managers and team members throughout study life cycle Ensure completion and application of all study-related documents Train internal and external team members on protocols, SOPs, and regulations Provide project management leadership for clinical and related disciplines Oversee clinical logistics, including product distribution and sample management Submit periodic reports on project status, costs, enrollments, and risks Respond promptly to internal and external stakeholder queries Collaborate on annual SOP reviews and process improvements The Senior Director of Clinical Operations should have the following qualifications: Bachelor's in life sciences or equivalent; advanced degree preferred 8+ years industry experience, including CRO management and clinical trial leadership Knowledge of ICH/GCP, FDA/EMA regulations, and quality standards; international study experience preferred Experience with clinical SOPs, CSRs, INDs, and other regulatory documents Strong communication skills; ability to work with senior management Proven collaboration with stakeholders, collaborators, and clinical sites Values creativity, passion, and independent thinking Benefits: 5 weeks PTO Free access to company gym Catered Lunches If you are interested in the Senior Director of Clinical Operations role, then please don't wait to apply.
US$234000 - US$265000 per year
San Diego
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Clinical Trial Manager/Senior Manager
Location: Seoul, Korea Therapeutic Areas: Cardiovascular, Infectious Disease, CNS/Neuroscience An award-winning global Clinical Research Organisation with international reputation in providing Phase 1 to Phase IV clinical development services is looking for a Clinical Trial Manager to be based in South Korea. This opportunity provides amazing growth potential, career progression and the chance to be working with a growing company. Responsibilities: Lead projects for multi-service global clinical trials Manage project timelines and deliverables Lead cross functional teams - clinical monitoring, study start-up, regulatory, contract, safety, medical monitoring. Secure new businesses Requirements: Bachelor's degree (Masters or PhD preferred) Relevant experience in clinical trial management in Asia, in a CRO is preferred Preferably a tertiary education in law and/or experience within the Chinese legal jurisdiction Good communication skills and team spirit If you are interested, please apply with your CV attached.
Negotiable
Seoul
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CRA
Title: Clinical Research Associate Salary: $120,000-$150,000 Company Summary: We're partnered with an ADC focused Biotech company that 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 Research Associate will be responsible for: Conduct Site Evaluation, Site Initiation, Interim Monitoring, and Close-Out Visits. Prepare the study reference manual, coordinating with the CRO team to ensure efficient delivery of materials to investigator sites. Ensure investigator sites meet all contractual and regulatory requirements for initiation and the first release of study drugs. Assist in developing study/program plans, including the Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, and Safety Management Plan. Manage patient recruitment strategies, identify barriers, and propose solutions such as webinars and newsletters. Liaise with site personnel to ensure accurate and timely data entry into the eCRF and resolve data queries promptly. Maintain project files, including ethics approvals, investigator CVs, study materials, and site correspondence. Assist with data listing, coding, patient profile reviews, database lock, and site close-out activities. Ensure timely submission of documents to the Trial Master File. Conduct investigational product inventory and reconciliation, ensuring compliance with protocol for dispensing and administration. Verify any issues related to blinded or randomized information. The Clinical Research Associate should have the following qualifications: 5 years monitoring oncology trials independently conducting on-site and remote monitoring visits 5-7 years of experience in oncology trials Ability to travel as required (50-75%) Benefits 401k with company matching. Health insurance with excellent family plan. Pre-IPO with equity offerings.
US$120000 - US$150000 per year
United States of America
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Director, TMF Operations
Title: Director of Clinical Operations, Greater Boston Area, Hybrid Salary: $200,000-$230,000 Company Summary: We just partnered with one of the hottest biotech's around at the moment that is growing its clinical 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 well-established big pharma. Here, they were able to get multiple blockbuster drugs approved. This company is one that has potential well beyond just one blockbuster drug due to their proprietary drug discovery platform. This exciting company has applications in oncology, neurology and immunology. 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 director of TMF Operations will be responsible for: Lead TMF Operations to support Clinical Research and Development. Oversee TMF vendor relationships, resolving issues and ensuring compliance. Ensure proper chain-of-custody at on-site and off-site TMF facilities. Develop and implement TMF processes, procedures, and training materials that comply with regulations and industry standards. Collaborate with cross-functional teams to maintain TMF completeness and accuracy throughout the trial lifecycle. Ensure quality control of TMF documents from start-up to archival. Monitor and report TMF metrics to senior management, highlighting improvement areas. Report TMF readiness to Clinical Trial Teams, including study-specific reviews. Identify root causes of performance issues and implement corrective actions. Stay updated on regulatory changes and best practices for continuous improvement. Manage eTMF platform configurations and monitor their impact. Oversee the sponsor archive's contents and access. The director of clinical operations should have the following qualifications: 10-12 years of experience with TMF operations 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 Proficient knowledge of DIA TMF Reference Model Experience in managing a team and providing leadership to drive performance Ability to work onsite at least 3 days a week Benefits 401k with company matching. Health insurance with excellent family plan. Pre-IPO with equity offerings.
US$200000 - US$230000 per year
Jersey City
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Clinical Research Associate
Title: Clinical Research Associate Salary: $120,000-$150,000 Company Summary: We're partnered with an ADC focused Biotech company that 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 Research Associate will be responsible for: Conduct Site Evaluation, Site Initiation, Interim Monitoring, and Close-Out Visits. Prepare the study reference manual, coordinating with the CRO team to ensure efficient delivery of materials to investigator sites. Ensure investigator sites meet all contractual and regulatory requirements for initiation and the first release of study drugs. Assist in developing study/program plans, including the Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, and Safety Management Plan. Manage patient recruitment strategies, identify barriers, and propose solutions such as webinars and newsletters. Liaise with site personnel to ensure accurate and timely data entry into the eCRF and resolve data queries promptly. Maintain project files, including ethics approvals, investigator CVs, study materials, and site correspondence. Assist with data listing, coding, patient profile reviews, database lock, and site close-out activities. Ensure timely submission of documents to the Trial Master File. Conduct investigational product inventory and reconciliation, ensuring compliance with protocol for dispensing and administration. Verify any issues related to blinded or randomized information. The Clinical Research Associate should have the following qualifications: 5 years monitoring oncology trials independently conducting on-site and remote monitoring visits 5-7 years of experience in oncology trials Ability to travel as required (50-75%) Benefits 401k with company matching. Health insurance with excellent family plan. Pre-IPO with equity offerings.
US$120000 - US$150000 per year
Utah
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