Senior Clinical Trials Scientist

Role overview The Senior Clinical Trials Scientist at CG Oncology, Inc. provides scientific leadership for Clinical Development and Operations. This remote position (United States) guides the scientific and strategic direction of global Phase II-III clinical trials. While this role does not include direct reports, it leads trial execution and serves as a key…

Position Overview: We are seeking a dedicated Clinical Trial Manager or Senior Clinical Trial Manager to take the lead in planning, conducting, and overseeing the operational aspects of clinical studies. You will ensure that all clinical trials are executed according to the established protocols, standard operating procedures (SOPs), ICH-GCP guidelines, and applicable regulatory requirements. Key Responsibilities: Act as the primary clinical contact for clients. Work collaboratively with project managers on monthly invoicing and clinical budget variance management. Create and maintain study-related clinical documents, including clinical plans, informed consent form templates, study-specific forms, manuals, CRF completion guidelines, study trackers, PSV/SIV slides, and other training materials. Identify and address training needs for Clinical Research Associates (CRAs) and third-party vendors, including presentations at investigator meetings and study kick-off sessions. Generate a list of potential sites from key stakeholders and lead the site feasibility process. Assess risks to enrollment targets based on feasibility analysis and site commitments. Devise and finalize recruitment and retention strategies for each country involved in the study. Establish effective communication and relationships with investigators and the study team to facilitate feasibility, site start-up, enrollment, maintenance, and close-out procedures. Lead internal clinical team meetings, setting clear expectations for CRAs and Clinical Trial Assistants (CTAs). Respond to all CRA and site inquiries while maintaining a Frequently Asked Questions (FAQ) log as necessary. Assist in planning and conducting investigator meetings. Review and approve investigational product release packages. Oversee and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in collaboration with regulatory departments as required. Develop clinical monitoring strategies to ensure study timelines and quality deliverables are met. Utilize metric reporting tools (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to confirm compliance with study plans and communicate issues to project managers and CRAs as needed. Manage the implementation and oversight of the electronic Trial Master File (eTMF).

About Us:Oruka Therapeutics (Nasdaq: ORKA) is at the forefront of developing innovative biologics that aim to revolutionize the treatment of chronic skin diseases. Our mission is to empower patients suffering from conditions like plaque psoriasis with unprecedented freedom from their ailments by achieving complete disease clearance with treatment regimens as infrequent as once or twice a year. We are advancing a proprietary portfolio of potentially best-in-class antibodies, engineered by Paragon Therapeutics, targeting the fundamental mechanisms behind plaque psoriasis and other dermatological and inflammatory disorders. For more detailed information, please visit www.orukatx.com.As we cultivate our core team, we are in search of exceptional talent across various functional areas—individuals who are not merely seeking a job but are enthusiastic about being part of a larger vision. We seek those who are passionate about making a meaningful impact and are eager to contribute to fostering an engaged, inclusive, and positive company culture.Role Overview:The Clinical Trial Manager/Senior Clinical Trial Manager will be responsible for ensuring compliance with trial protocols, regulatory requirements, and overall trial execution.

We are looking for a dedicated Senior Clinical Trial Management Associate to join our team. In this role, you will oversee the planning, execution, and management of clinical trials, ensuring compliance with regulatory standards and timelines. Your expertise will help drive our projects forward, providing crucial support to our clinical research teams.

At Olema Oncology, we are committed to advancing innovative treatments for breast cancer and beyond. Our flagship program, palazestrant (OP-1250), represents a pioneering complete estrogen receptor antagonist (CERAN) currently under investigation for metastatic breast cancer, with significant potential both as a standalone therapy and in combination with existing treatments for ER+/HER2- metastatic breast cancer. Furthermore, our subsequent candidate, OP-3136, is a promising KAT6 inhibitor expected to set new standards in efficacy.We foster an environment of scientific excellence through unwavering support, motivation, and constructive challenges among our team members. At Olema, prioritizing our people ensures our work stands out in the industry. If you are prepared to embark on an exciting journey with us and make a meaningful difference for our patients, your career, and the future of medicine, we want to hear from you.Explore our latest corporate presentations here.About the Position: Senior Clinical Trial AssociateAs a Senior Clinical Trial Associate, you will report directly to the Senior Manager, Clinical Trial Leader, and provide essential administrative and operational support to our clinical teams throughout all phases of the study lifecycle, including both in-house and outsourced trials. Your role will facilitate seamless study execution through collaboration with internal teams, external vendors, and site personnel. This includes contributing to essential study documentation such as informed consent forms (ICFs) and central IRB submissions, managing site payments, and overseeing various operational tasks related to the study. You will also serve as a liaison to investigator sites, ensuring effective communication and follow-up.Your responsibilities will encompass assisting with study initiation, maintenance, and closure activities; managing study documentation and materials; supporting vendor management; and maintaining accurate study trackers and financial records. This role adheres strictly to Clinical Standard Operating Procedures and Good Clinical Practice (ICH) guidelines.This position is available in either our San Francisco or Cambridge office and will require approximately 10% travel.Your core responsibilities include:Supporting the Clinical Trial Lead (CTL) and Study Execution Team (SET) by ensuring accurate and comprehensive documentation of study conduct.Managing study-related vendors and acting as the primary contact for contracted CROs, study personnel, contract laboratories, and other relevant vendors.Being a key point of contact for investigator sites...

About Us:Oruka Therapeutics (Nasdaq: ORKA) is pioneering innovative biologics aimed at redefining the treatment landscape for chronic skin conditions. Our mission is to provide individuals afflicted by chronic skin diseases, such as plaque psoriasis, with unparalleled freedom from their ailments through therapies that may require administration only once or twice annually. We are advancing a unique portfolio of potentially leading antibodies, engineered by Paragon Therapeutics, that target the fundamental mechanisms of plaque psoriasis and other dermatologic and inflammatory conditions. To learn more, please visit www.orukatx.com.As we expand our core team, we are on the lookout for exceptional talent across various functional areas. We seek individuals who are not only searching for employment but also aspire to be part of a transformative mission. If you are passionate about making a meaningful impact and are eager to help cultivate a vibrant, inclusive, and positive organizational culture, we encourage you to apply.Job Title: Senior Clinical Trial ManagerLocation: Hybrid – Waltham, MA. Candidates are expected to work in the office 3 days per week.Role Overview:The Senior Clinical Trial Manager will act as the clinical functional lead, spearheading clinical trial initiatives for Oruka's innovative dermatological treatments. You will be responsible for ensuring compliance with trial protocols, regulatory standards, and operational efficiency while collaborating with cross-functional teams to propel Oruka's clinical pipeline forward. A Senior Clinical Trial Manager is expected to manage the clinical trial independently, effectively planning and executing the study to guarantee the quality of deliverables within the specified budget and timeline.Key Responsibilities:Clinical Trial Management:Lead and oversee multiple clinical trials from initiation through completion, ensuring compliance with study timelines and financial parameters.Collaborate with investigators, vendors, and cross-functional teams to assure excellent study execution and operational performance.Supervise the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and study reports.

Umoja Biopharma is seeking a Senior Clinical Trial Manager to guide clinical trial operations. This role offers flexibility to work remotely or from the Seattle, Washington office. Key responsibilities Lead the design, execution, and oversight of clinical trials for Umoja Biopharma's therapies Collaborate with internal teams and external partners to coordinate all trial activities Maintain strict adherence to regulatory requirements and company protocols Prioritize patient safety and uphold data integrity throughout each study Requirements Experience managing clinical trials and working with cross-functional teams is essential. Familiarity with regulatory standards and a focus on patient safety are important for this position. Location This position is open to remote candidates within the United States or those based in Seattle, Washington.

The Alliance for Clinical Trials in Oncology Foundation is dedicated to advancing cancer clinical research by expanding the capabilities of the Alliance for Clinical Trials in Oncology. Our mission is to address significant treatment challenges through large-scale clinical trials aimed at discovering innovative methods for the prevention, treatment, and cure of various cancers, including leukemia, lymphoma, and solid tumors such as breast, prostate, lung, and gastrointestinal cancers. We also strive to educate the medical community on effective cancer diagnosis, treatment, and prevention strategies.In 2014, we established the Alliance Foundation Trials, LLC (AFT), a wholly-owned subsidiary focused on conducting impactful cancer clinical research in collaboration with industry partners.We are currently seeking a Clinical Research Associate (CRA) to play a crucial role in the management and execution of clinical trial operations across AFT studies. The CRA will be responsible for site management and study start-up activities, including conducting feasibility assessments, supporting site selection, maintaining trial master files (eTMF), and overseeing clinical trial management systems (CTMS). The ideal candidate will work closely with CROs, vendors, and investigative sites to ensure compliance with ICH GCP guidelines and organizational standards throughout the study lifecycle. Join our team of dedicated professionals passionate about transforming cancer care.

About Oruka Therapeutics Oruka Therapeutics (Nasdaq: ORKA) develops biologic therapies for chronic skin conditions. The company focuses on giving patients with diseases like plaque psoriasis greater freedom through infrequent dosing, just once or twice a year. Oruka’s pipeline features proprietary antibodies from Paragon Therapeutics, designed to address the underlying mechanisms of plaque psoriasis and other dermatologic or inflammatory disorders. Learn more at www.orukatx.com. Position Details Title: Clinical Scientist, Clinical Development (Multiple openings) Location: Hybrid (Waltham, MA) with an expectation of three days per week in the office. Remote candidates will also be considered. Role Overview The Clinical Scientist plays a key role in planning and executing clinical trials. This position supports the development of study protocols, assists with implementation, reviews clinical data, and helps prepare documentation to meet clinical development goals. The Clinical Scientist works closely with cross-functional teams and reports directly to the Medical Director of Clinical Development to help deliver high-quality clinical data. Main Responsibilities Clinical Trial Design and Oversight: Help develop clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods. Monitor clinical trial data at study sites to ensure adherence to protocols and Good Clinical Practice (GCP) standards.

About the Role Mammoth Biosciences seeks a Senior Clinical Scientist to help advance pre-clinical research into clinical trials. Based in Brisbane, CA, this position combines hands-on trial design with broader project strategy. The Senior Clinical Scientist reports to the VP of Clinical Development. What You Will Do Design and execute clinical trials, ensuring studies are set up and run according to protocol Work closely with the medical monitor, operations team, contract research organizations (CROs), and study sites Support subject recruitment and follow-up, maintaining compliance with regulatory and study requirements Compile and analyze study data for internal and external reports Prepare materials and data for key meetings Collaboration This role involves frequent collaboration with internal teams and external partners to ensure data accuracy and regulatory compliance throughout clinical trial activities.

Join our dynamic team as a Clinical Trial Leader, where you will be at the forefront of innovative clinical research. You will be responsible for overseeing the planning, execution, and management of clinical trials, ensuring compliance with all regulatory requirements and organizational standards. Your leadership will guide cross-functional teams to deliver high-quality results, contributing to the advancement of healthcare solutions.

Adicet Bio, Inc. is seeking a Senior Clinical Trial Manager to lead the planning and execution of clinical trials in a dynamic and collaborative environment. In this role, you will oversee all aspects of clinical trial management, ensuring compliance with regulatory requirements while achieving project milestones and objectives.

As a Senior Associate for Clinical Trial Transparency at Integrated Resources, Inc., you will play a pivotal role in ensuring the integrity and transparency of clinical trial data. This position involves collaborating with clinical teams to develop and implement strategies that align with regulatory requirements and promote public trust in clinical research. You will leverage your expertise to maintain compliance and enhance the visibility of our clinical trials.

Join our dynamic team as a Clinical Trial Assistant where you will play a pivotal role in supporting clinical research projects. As a key member of our team, you will assist in the management and coordination of clinical trials, ensuring compliance with regulatory standards and facilitating communication among stakeholders.

Join DLH Corporation as a Clinical Trials Specialist, where you will play a pivotal role in the management and coordination of clinical trials. In this position, you will be responsible for ensuring compliance with regulatory requirements, collaborating with cross-functional teams, and facilitating effective communication between stakeholders. Your expertise will contribute significantly to the advancement of critical healthcare solutions.

Join Integrated Resources, Inc. as a Clinical Research Scientist, where your expertise will drive innovative research initiatives. As a vital member of our team, you will collaborate with cross-functional teams to design, implement, and oversee clinical trials that advance medical knowledge and enhance patient care. Your analytical skills will be essential in evaluating trial results and ensuring regulatory compliance at every stage.

Become a Pioneer in the Sleep Fitness RevolutionJoin Eight Sleep, where our mission is to enhance human potential through exceptional sleep quality. As the world's first sleep fitness company, we are transforming the concept of well-being and creating cutting-edge hardware, software, and AI technology to facilitate optimal sleep. Our innovative products are designed to maximize mental, physical, and emotional performance, turning each night into a personalized, data-driven recovery session. Trusted by elite athletes and health-conscious individuals across over 30 countries, we are at the forefront of the sleep revolution.Featured as one of Fast Company's Most Innovative Companies in multiple years, we are committed to building a high-performance team that prioritizes speed, focus, and impactful results. Our culture is characterized by an obsession with detail and continuous improvement to ensure our members achieve better sleep and stronger mornings.Unwavering Standards and CommitmentOur intensity reflects the demands of our mission at Eight Sleep. We strive for excellence, inspired by the dedication of top performers worldwide. We are a team that operates with focus and tenacity, constantly pushing to excel in our craft. This is not a conventional 9-to-5 job. Our team is deeply engaged, often going above and beyond because we are passionate about our work.If you thrive under pressure and seek to make a significant impact in your career, you will find your place here. However, if you prefer an easy-going environment, this may not be the role for you.Your RoleWe are in search of a Senior Clinical Trial Manager to oversee the comprehensive execution of our clinical studies, including regulatory trials. This operationally intensive role requires a hands-on approach and expertise in initiating studies from the ground up, managing third-party clinical sites, drafting IRB and informed consent documents, overseeing data management, and ensuring timely and budget-compliant study completion.You will serve as a vital link between our internal teams and external clinical sites, investigators, IRBs, CROs, and, when needed, study participants. A strong understanding of regulatory requirements for medical devices and a proven track record of successful clinical study delivery supporting regulatory submissions are essential.

We are seeking a motivated and detail-oriented Clinical Trials Management Associate to join our dynamic team at Integrated Resources Inc. In this role, you will play a crucial part in coordinating and managing clinical trials, ensuring compliance with regulatory requirements, and supporting our research initiatives. You will work closely with cross-functional teams to facilitate the successful execution of clinical studies.

We are seeking a dedicated and skilled Clinical Research Scientist to join our innovative team at Artech Information Systems LLC. In this role, you will contribute significantly to the development and execution of clinical trials. Your expertise will be essential in ensuring compliance with regulatory requirements and maintaining the highest standards of research integrity.

We are seeking a motivated Clinical Project Scientist to join our dynamic team. In this role, you will be instrumental in driving clinical trials and ensuring the highest standards of research integrity. You will collaborate with cross-functional teams to design, implement, and oversee clinical studies, ensuring compliance with regulatory requirements and company policies.