Theradex Oncology

Role Description As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered. As part of the team, you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference. Clinical Project Manager or Sr Clinical Project Manager based on experience. Location: USA Remote Theradex Project Managers oversee global phase I – III oncology clinical trials from feasibility and startup through closeout to ensure processes, timelines, contracts, ICH/GCP adherence and quality standards are met. As a key point of contact, you'll interface directly with sponsors, vendors, cross-functional team members, and investigative sites. You'll identify and evaluate risks, interpret data on complex issues, and implement solutions to ensure successful completion of oncology trials. Key Responsibilities - Clinical Project Leadership: Drive the successful execution and proactive management of clinical projects. Serve as the subject matter expert for assigned protocols and provide guidance to cross-functional study teams. - Study Oversight: Monitor study enrollment, retention, and metrics to identify trends and act on deviations. Develop and implement strategic solutions for recruitment and retention challenges. Ensure accurate study information is reflected in status reports and clinical trial platforms. - Risk and Quality Management: Proactively identify and communicate operational risks, aligning with the study team on mitigation strategies. Oversee the development and adherence to study-specific oversight and Corrective and Preventive Action (CAPA) plans. - Compliance and Audits: Manage the Trial Master File (TMF) for Clinical Operations documentation and ensure inspection readiness. Collaborate with Quality Assurance for internal and external audits. - Budget and Timelines: Proactively manage study-specific timelines and budgets. Review and approve invoices and timesheets. Identify and initiate Change Order (CO) activities as required to maintain project scope. - Team Management: Lead and manage the day-to-day activities of the study team, including leading team meetings and conducting study-specific training. Qualifications - BS required – preferably in a life science field or equivalent (includes RN degree) - MS or PhD preferred - Healthcare professional with at least 4 years of clinical experience, or Science Graduate with at least 4 years experience in clinical research, with a track record in successfully managing clinical trial sites - Prior project management experience required - High level of proficiency with Excel and MS Office; ability to master various electronic platforms for data entry and clinical trial management - Experience with oncology clinical trials and/or cancer therapies is highly preferred (required for senior level project managers) - Prior involvement with CAR-T or other gene/cell therapies is highly preferred - Prior experience in a CRO/pharmaceutical environment preferred (required for senior level project managers) - Must be fluent in English (verbal and written) Skills and Competencies - Well-developed critical thinking and analytical skills, with the ability to anticipate problems relating to projects and to develop and implement solutions - Able to seek out multiple and diverse perspectives; open to continuously refining your approach based on feedback and new information - Knowledgeable of the initiation, conduct, and completion of clinical trials, study endpoints, and clinical databases - Well-developed and effective written and verbal communication skills, including report writing, preparing, and delivering presentations, and various correspondence and meeting platforms - Effective knowledge of the drug development process Additional Requirements - Ability to travel occasionally up to 30% when required, domestic and/or global - Valid Driver’s License an advantage - Basic knowledge of one (or more) European language an advantage Benefits - Comprehensive benefits package including medical, dental, and vision coverage - Life insurance and disability insurance (STD/LTD) - Company matched 401(k) - Very competitive tuition reimbursement - Generous vacation/sick plans - Flexible work schedules - Employee discounts and other company provided benefits - Annual base salary ranges from $105,000-$165,000 with bonus potential

Role Description Theradex is recruiting for a highly collaborative Senior Medical Writer with 5+ years experience to join our team. If you are a self-starter and want to be part of the full life-cycle of the regulatory medical writing process, this opportunity may be for you. The Senior Medical Writer will be part of the growing team within Theradex and have a client facing, collaborative role with direct involvement with medical monitors and senior leadership. The primary responsibilities of this position include, but are not limited to, the following: - Preparation of Initial Investigational New Drug (IND) applications and amendments - Clinical study protocols and protocol amendments - Investigator's brochures and updates - Interim and final clinical study reports - IND annual reports - Development safety update reports - Patient informed consent forms - Provide guidance and support to other in-house units in preparation or review of manuals, training guidelines and similar documents - Serve as a resource for new medical writers Qualifications - Bachelor’s degree required / Advanced degree preferred - 5+ years prior experience in a CRO/pharmaceutical environment - 3+ years prior relevant experience in regulatory Medical Writing (oncology required) - Lead writer experience on >3 of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures, Development Safety Update Reports, IND applications - Experience collaborating directly with clients/Sponsors, preparing document timelines, organizing review cycles, and coordinating review meetings - Proven experience with Fast Track Applications: INDs/BTDRs - Familiarity with eCTD modules - Familiarity with industry principles of drug safety, US and international regulatory guidelines, drug development, biostatistics, pharmacology, clinical trial methodology and oncology - Ability to work independently, meet deadlines and be results-oriented - Ability to manage critical issues on multiple projects simultaneously - Function as a team-player, highly organized, self-motivated, and extremely detail-oriented - Strong oral and written communication skills, excellent interpersonal skills, and advanced computer literacy of MS Office Suite Benefits - Friendly and supportive culture that puts people first - Competitive compensation and benefits package as per country requirements Company Description Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.

Who We Are Celebrating 40+ Years! Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease. What You'll Do We are hiring a Freelance SCRA (Romanian Speaker) based in Romania a 0.3 FTE per month for a 12 months contract. The primary responsibilities of this position include, but are not limited to, the following: - Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, study manuals/binders, etc. - Maintain an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice. - Collaborate with other members of the project team to meet Sponsor, Protocol and Theradex objectives of Regulatory Readiness including contract and budget negotiations, as required. - Establish and maintain effective, routine communications with study sites , providing timely study updates and support to sites. - Establish and maintain effective, routine communications with the internal project team, providing timely project team updates on site related issues. - Responsible for assisting in the preparation of the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies. - Maintain up-to-date site information (including all contact details and distribution lists for reports and clinical supplies). - Performs ongoing management of essential regulatory documentation at the outset and across the lifespan of a study - Performs quarterly QC of assigned studies/sites in the eTMF according to Theradex Oncology SOP. - Performs study tracking via CTMS, investigator site file tracker (if utilized) and/or sponsor designated system to ensure that the study files are current, accurate and complete. - Ensures protection of subjects, subjects’ rights, and the integrity of data through adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures, and protocol compliance. - Participate in the conduct of pre-qualification, initiation, routine monitoring, remote monitoring, and close-out visits in accordance with the relevant SOPs - Proactively identify and resolve potential site and study issues. - Identify and escalate data quality issues to ensure clinical data integrity - Provide support to project management via ongoing project reports and updates. - May be responsible for supporting multiple studies simultaneously What You Need Level of Education: - At minimum, Bachelor's degree (BSc, BA, or RN equivalent) in biological or human science-related field or equivalent experience. Prior Experience: - At least 5 years’ experience as a Clinical Research Associate with a sound track record in managing clinical trial sites - Experience in on-site monitoring oncology early phase studies Skills and Competencies to be demonstrated: - Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements. - Highly effective multitasking and execution skills. - Excellent interpersonal skills, including communication, presentation, persuasion, and influence. - Excellent organizational skills, including efficiency, punctuality, and collaboration in a team environment. - Knowledgeable in the identification, anticipation, and reporting to appropriate management problems relating to study conduct, and highly effective in developing solutions to those problems - Effective knowledge of the drug development process and the Theradex organizational structure - Strong communication skills: verbal and written - High level of proficiency in Microsoft Outlook, Word and Excel - Candidates must be fluent in Romanian - Candidate must be fluent in English. What we offer: Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment.

Who We Are Celebrating 40+ years! Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials. What You'll Do As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will the work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference. Opportunity Clinical Research Associate (CRA) – All levels (I/II/Senior) We are expanding our team and are looking to hire CRAs for onsite and remote monitoring of phase l-lll oncology studies. The primary responsibilities of this position include, but are not limited to, the following: Conduct Site Monitoring: - Site Qualification visits - Site Initiation visits - Routine Monitoring visits - Close-out visits - All aspects of site management as described in the study plans Source document verification: - Verify patient eligibility - Reviews consent process for each subject (Informed Consent Form and source documentation) - Assess protocol compliance and deviations - CRF review and data corrections - IMP accountability - Maintenance of on-site investigator files - IEC/IRB documentation - Local laboratory documentation - Maintenance of investigational supplies - Identify and assess safety issues and reporting (SAEs/AEs) Site Management: - Ensure protection of participants and participants' rights - Proactively identify and resolve actual and potential site and study issues - Ensure clinical data integrity and adherence to study timelines - Clinical Review of individual patient listings - Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc. - Act as the routine liaison between study site and the project team for study related issues - Perform other duties as assigned by management What You Need Level of Education - At minimum, Bachelor's degree in biological or science-related field (BSc, BA, or RN equivalent) or equivalent experience. Prior Experience - As a Clinical Research Associate with experience managing clinical trial sites, the number years and type of monitoring experience will determine CRA level. - Experience in monitoring early phase oncology studies is preferred. Skills and Competencies - Knowledge of ICH/GCP Guidelines, and Regulatory requirements - Ongoing development of cancer therapy knowledge, clinical trial design and conduct, and drug development process through work experience, literature reviews and other educational opportunities - Proficient in Excel, PowerPoint, Word, and Outlook - Skilled remote collaboration and teleconferencing platforms - Strong organizational skills, including efficiency, punctuality, and collaboration in a team environment. - Effective communication skills: verbal and written - Strong interpersonal skills including presentation, persuasion, and influence Additional Requirements - This position involves travel as needed to meet study requirements. Ability to travel up to 50% may involve overnight stays. - Valid Driver’s License required and Passport preferred - Successfully pass background clearance checks which may be run on a periodic basis due to 3rd party contractual obligation requirements. - Fluent in English (written and verbal) What We Offer At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for our CRA positions range from $75,000-$145,000 with bonus potential. We will assess the specific title and level of entry during the interview and assessment process since the actual salary offer will be based on a number of factors, including but not limited to the candidate’s qualifications, experience, skills, and competencies for the role. This position is not eligible for company provided sponsorship or relocation. Theradex is not accepting assistance from search firms for this employment opportunity. Theradex is an Equal Opportunity Employer.

Who We Are Celebrating 40+ years! Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials. What You'll Do As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference. Opportunity Senior Full Stack Engineer - Contract Location: Princeton NJ and Remote – Preference given to applicants residing on the East Coast. We are seeing a Contract Senior Full Stack Engineer to design, build, and deliver modern, production-grade applications across the full technology stack. This role is hands-on and execution-focused, with responsibility for solution quality, performance, and usability. The position includes providing technical direction, guidance, and mentorship to mid-level and junior developers. Responsibilities will include: - Design, develop, and maintain end-to-end full stack solutions, including frontend, backend services, APIs, and data integrations - Build modern, responsive, and intuitive user interfaces, working closely with UX and product partners - Define and implement scalable, secure, and maintainable technical solutions for production environments - Translate product and business requirements into clear, well-structured technical designs - Provide ongoing technical guidance, code reviews, and implementation support to mid-level and junior developers - Promote and enforce best practices for coding standards, testing, CI/CD, and deployment - Take ownership of complex features and workflows from design through production release - Ensure application performance, reliability, security, and operational stability - Collaborate closely with product managers, designers, and stakeholders throughout the delivery lifecycle - Contribute to technical documentation, knowledge sharing, and continuous improvement initiatives . What You Need - Bachelor's degree required, Advanced degree preferred - 4–6 years of professional software development experience in full stack roles - Experience with end-to-end project to include gathering requirements, UX, production and deployment - 2+ years experience with .Net Core & C# - Strong experience with modern frontend frameworks (e.g., React, Angular, or Vue) - Solid backend development experience - Experience designing and consuming RESTful APIs - Working knowledge of relational and/or NoSQL databases - Experience building, deploying, and supporting production-grade applications - Familiarity with cloud platforms (AWS, Azure) and CI/CD pipelines - Strong understanding of software engineering fundamentals, testing strategies, and version control - Able to work effectively as a remote worker. - Possibility of occasional domestic travel for face-to-face meetings or training. Advanced notice will be provided. - Skills and Competencies - Agile/Scrum methodologies and sprint planning in a team environment - Experience with secure coding, performance optimization, observability (logging, metrics and tracing) in production systems - Proven track record owning technical decisions and deliver outcomes for a project or product area. - Extensive experience as a full stack developer, including delivering at least one complex system from concept to production - Strong analytical and organizational skills with the ability to prioritize tasks and track assignments to meet the needs of internal and external clients. - The ability to convery or share ideas in a concise terms that others understand. - Works to establish and maintain positive working relationships while offering added value and insight. - Guides others to strengthen their knowledge, skills, and abilities to accomplish goals. - Must have strong communication skills and be fluent in English. At Theradex we offer a supportive culture that puts people first. The annual base salary for this position ranges from $135,000-170,000. The actual salary offer will be based on a number of factors, including but not limited to the candidate’s qualifications, experience, skills, and competencies for the role. This is a contract position and not eligible for relocation or company provided sponsorship. Theradex is an Equal Opportunity Employer.