(Senior) Manager Clinical Trials Data Management

Bioptimus is building the first universal AI foundation model for biology to fuel breakthrough discoveries and accelerate innovation in biomedicine. With more than $75M in funding, Bioptimus is a fast-growing start-up headquartered in Paris, incorporated in October 2023. Backed by leading international venture capitalists, our world-class team of scientists and engineers is redefining the frontiers of AI and life sciences.  CLINICAL DATA MANAGER (SENIOR) Bioptimus’ mission is to accelerate biomedical innovation by building the reference foundation model of biology that will unlock AI superpowers for the biomedical ecosystem. As a well-funded and fast-growing start-up headquartered in Paris and incorporated in October 2023, we are growing a world-class team of scientists, engineers, and product leaders. This is a remote role. We’re headquartered in Paris, but the position can be performed remotely outside of Paris. ABOUT THE ROLE We are looking for a technical, execution-focused Clinical Data Manager to bridge the gap between unstructured, real-world data, and our frontier AI models. In this role, you will be the authority on clinical data structures, serving as the technical link during conversations with our global partners to standardise and harmonise data pipelines. Operating within our STELA program, you will structure our clinical datasets. You are a hands-on technical expert who writes reproducible code, enforces incoming data QC, and designs the data dictionaries and ontologies for our models. ABOUT THE STELA PROGRAM We recently launched the Spatial Tissue Embedding Learning Atlas (STELA)—a multinational spatial data generation initiative anchored by strategic partnerships with 10x Genomics and Broad Clinical Labs. STELA serves as the data backbone for M-Optimus, aiming to profile up to 100,000 patient specimens across three continents (US, Europe, and Asia). This will integrate high-resolution spatial transcriptomics, histopathology imaging, and longitudinal clinical records to bring forward the next era of biological AI and precision medicine. WHAT YOU'LL BE DOING ---------------------------------------------------------------------------------------------------------------------------------- As our Clinical Data Manager, you will operate at the intersection of data engineering, clinical science, and partner collaboration across two strategic domains: PARTNER DATA ENGINEERING & COLLABORATION * Technical Partner Interface: Participate directly in technical conversations with external partners (hospitals, research institutions, CROs/CMOs). Dive into the details of diverse clinical data structures to understand how data is captured, stored, and extracted. * Order from Uncertainty: Translate ambiguous source data into harmonized, AI-ready assets. * Ontology Integration: Map and align diverse clinical data to industry-standard biomedical ontologies (e.g., SNOMED, ICD, etc…) with an emphasis on clinical oncology and immunology data. DATA GOVERNANCE, QUALITY, AND AUTOMATION * Data Dictionary Architecture: Design, build, and maintain data dictionaries, schemas, and metadata models that align with STELA’s multimodal pipeline requirements, while ensuring integration with existing pipelines. * Enforcing Ingest Quality: Establish, automate, and enforce data quality control (QC) and validation frameworks to check incoming partner data for integrity, completeness, and programmatic consistency. * Reproducible Pipeline Code: Write production-grade Python code to automate data cleaning and harmonization tasks. CLINICAL REALITY & INTUITION * Clinical Reality: Practical understanding of how clinical data is generated in the real world (hospitals, trials, CROs). You understand the gaps between ideal protocols and messy clinical realities, and you know what red flags to look for in incoming data. * The Investigative Mindset: You know what questions to ask partners to get to the "ground truth" of their data structures. Actively audit data to find missing variables, anomalies, and hidden biases. * Oncology/Immunology Domain Knowledge: Familiarity with cancer progression metrics (e.g., RECIST criteria, TNM staging, longitudinal treatment lines like immunotherapy vs. chemotherapy) so you can recognize what data is important.   WHAT YOU'LL BRING ---------------------------------------------------------------------------------------------------------------------------------- The successful candidate will have a ‘team-first’ attitude; be independent, curious, and detail-oriented; thrive in a dynamic, fast-paced environment; and be fun to work with. You possess the rare ability to confidently lead complex technical alignment meetings with partners while simultaneously being excited to roll up your sleeves and write code. TECHNICAL & PROFESSIONAL QUALIFICATIONS * Educational Background: Bachelor’s or Master’s degree in Life Sciences, Bioinformatics, Health Informatics, Computer Science, Statistics, or a related quantitative field. Equivalent practical industry experience is highly valued. * Industry Experience: A few years (typically 3–5+) of hands-on experience in clinical data management or clinical data engineering within a CRO, CMO, pharma, or biotech environment. Proven track record of taking messy partner data and building reproducible, production-grade workflows. * Hands-on Coding Skills: High proficiency in Python and standard data science libraries (e.g., Pandas, NumPy) for data manipulation, cleaning, and validation. * Software Best Practices: Demonstrated commitment to code reproducibility, including strong experience with Git version control and building reusable data pipelines. * Clinical Data Expertise: Familiarity with clinical data structures, electronic health records (EHR), case report forms (CRFs), and longitudinal clinical trial data. * Ontologies & Vocabularies: Knowledge of standard clinical and biological ontologies, specifically those tailored to cancer/oncology and/or immunology datasets. PARTNERSHIP & EXECUTION SKILLS * Communication & Alignment: Ability to align on data delivery formats with a partner clinical teams. * Start-up experience: Comfort working in a fast-paced startup environment where data schemas evolve and ingest requirements must be defined from scratch.   HOW TO STAND OUT ----------------------------------------------------------------------------------------------------------------------------------   * Experience with cloud computing platforms (AWS, GCP, etc…) * Experience working directly with multimodal datasets (e.g., matching clinical records with omics or digital pathology imaging). * Understanding of CDISC standards (SDTM/ADaM) combined with a modern tech-stack approach (beyond legacy SAS programming). * Experience building or optimizing ETL pipelines for large-scale biobanks or multinational clinical consortia.   THE CANDIDATE JOURNEY ---------------------------------------------------------------------------------------------------------------------------------- To be considered, please submit your CV in English. We believe in a transparent and collaborative interview process. Here is what you can expect after submitting your application:   * Screening: A 30-minute introductory call with the Hiring Manager to discuss your background, motivations, and the position in more detail. * Interviews: Following a successful screening, you will be invited to a series of interviews: 1. Data Strategy Panel Presentation (45 min): You will present a short overview of a past data management challenge you overcame (e.g., designing a complex data dictionary or aligning messy CRO data), followed by Q&A. 2. Technical Deep Dive (30 min) - There will be 1 additional break out session to do a deep dive with 1-2 Bioptimus Engineers 3. Executive Interview (30 min): A discussion with member(s) of our Senior Leadership focusing on long-term vision, cultural fit, and mutual potential. * Offer: Following the completion of all interviews, our hiring team will make a final decision. Please note that an offer is contingent upon the successful completion of a reference check. * Onboarding: Welcome to the team! We will begin your onboarding to get you fully integrated at Bioptimus!   WHY THIS IS A UNIQUE OPPORTUNITY ----------------------------------------------------------------------------------------------------------------------------------   * Join a mission-driven team redefining biology through AI. * Work in a collaborative, high-autonomy, high-impact environment. * Contribute to pioneering research, infrastructure, or strategy at the ground floor. * Competitive compensation, equity, and flexibility (remote options). * Help shape the scientific and technical culture of a category-defining company. ----------------------------------------------------------------------------------------------------------------------------------   We believe that the unique contributions of all Bioptimists create our success. To ensure that our culture continues to incorporate everyone’s perspectives and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, or marital, or disability status. Decisions related to hiring are made fairly, and we provide equal employment opportunities to all qualified candidates. We take responsibility for always striving to create an inclusive environment that makes every employee and candidate feel welcome.

The Role We have an excellent opportunity for a Trainee Medical Writer to join our Medical Writing department, based in Edinburgh. You will be involved in the challenging environment of early phase clinical research and be trained in the many different aspects of medical writing. Data Sciences at Quotient Sciences comprises six departments (including Medical Writing) and over 100 staff and provides an expert service in the data management, analysis and medical writing of early phase clinical studies Working as part of the team, you will be responsible for: * Writing the study protocol (study design, objectives, methodology, etc.) before commencement of the clinical study * Writing the Clinical Study Report (study results, interpretation, conclusions, etc.) after completion of the clinical phase of the study and the availability of statistical results. * QC of study protocols and Clinical Study Reports * The role also involves working closely with other staff in our Medical Writing department and the Project Statistician, Pharmacokinetist, Programmer, Medic, Project Manager and Quality Assurance staff. Full training will be provided in medical writing processes and techniques. Dependent on your development, our career pathway allows you to expand your skills over time, take ownership of medical writing activities within Data Sciences project teams, and progress into more senior roles. The Candidate The successful candidate will have: * A degree with a strong scientific focus  * The ability to summarise/interpret data * A strong interest in developing a career in Medical Writing Desirable skills and experience  * Some prior experience working on Phase I-IV clinical trials (e.g. pharmacovigilance, monitoring, regulatory, knowledge of GCP, etc.), * Experience in medical communications and/or pre-clinical report writing (e.g. toxicology reports, GLP, etc.) would be an advantage. * Scientific qualifications such as an MSc or PhD would also be helpful. * Candidates with previous regulatory medical writing experience will be considered for a more senior role. Other essential skills and experience required are: * Proficient Microsoft Office skills including Word and Excel * Good organisational skills and the ability to work to deadlines whilst maintaining quality standards * Attention to detail and the ability to multitask * Effective oral and written communication skills   Eligibility to Work in the UK   Please note that this position is not eligible for sponsorship under the UK points-based immigration system. If you require sponsorship, we will be unable to progress your application or make an offer of employment.   As this is a permanent role, we are also unable to accept applications from candidates on a Graduate Visa.