Source Job

Europe

  • Lead operational delivery of Phase I clinical studies from start-up through close-out as the day-to-day counterpart to the CRO.
  • Own site relationships, drive activation readiness, and manage recruitment performance for complex dose-escalation studies.
  • Ensure quality and timeliness of clinical data, supplies, and vendor deliverables while maintaining ICH GCP compliance.

Clinical Operations CRO Management GCP

20 jobs similar to Senior Study Manager - IBD

Jobs ranked by similarity.

$130,000–$190,000/yr
US Unlimited PTO

  • Manage all clinical operational aspects of global trials including start-up, conduct, and close-out.
  • Oversee CRO and site adherence to GCP and SOPs, proactively identifying and resolving study risks.
  • Lead study team meetings, build investigator relationships, and support protocol development.

Vera Therapeutics is a commercial-stage biotech focused on transforming autoimmune disease treatment, starting with the kidney. Founded in 2016 in Brisbane, CA, the company values empathy, ownership, clarity, and urgency in a collaborative, fast-paced team.

$115,000–$135,000/yr
US Europe

  • Lead and coach a team of Clinical Study Operations professionals overseeing device-based clinical trials from feasibility to close-out.
  • Drive domain-level ClinOps initiatives including process standardization, tooling, and data quality improvements.
  • Represent ClinOps in business development conversations, feasibility discussions, and Investigator Meetings, ensuring operational readiness.

Beacon Biosignals transforms precision medicine for the brain, offering at-home EEG and diagnostic platforms for neurological, psychiatric, and sleep disorders. They are a remote-first, distributed company with hubs in Boston, New York, and Paris, emphasizing curiosity, sound judgment, and empathy.

EMEA

  • Lead Clinical Trial Liaison performance, development planning, and quality delivery across EMEA.
  • Oversee vendor-provided staff, implement standardised feasibility and site selection processes, and build investigator relationships.
  • Report monthly metrics, escalations, and best practices while retaining a 15% liaison workload.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, the company has a culture of innovation and has been recognized as a Great Place to Work.

Europe

  • Manage all clinical aspects of assigned studies across multiple countries, ensuring timeline adherence and quality.
  • Lead CRAs and support site selection, start-up, enrolment, monitoring, data cleaning, and close-out.
  • Identify risks to timelines and collaborate with teams to deliver high client satisfaction.

Precision for Medicine is a precision medicine CRO combining novel trial designs, operational experts, and biomarker analytics with a focus on oncology and rare diseases. It encourages high-energy professionals who thrive in dynamic environments.

France

  • Monitor clinical studies at investigative sites to ensure compliance with protocols, SOPs, and ICH-GCP.
  • Coordinate study setup and initiation activities, including investigator identification and regulatory submissions.
  • Identify study risks and propose mitigation strategies while maintaining high quality and detail.

Precision for Medicine is a CRO integrating clinical trial execution with scientific expertise and data sciences, focusing on Oncology and Rare Disease. It offers a supportive, small-CRO culture with high CRA retention and emphasis on work-life balance.

Global

  • Lead and oversee global Phase 0-4 clinical trials with cross-functional teams from inception to closure.
  • Manage external vendors, recruitment strategies, and study systems to ensure quality, efficiency, and inspection readiness.
  • Collaborate with study project managers to drive timelines, budgets, and compliance with ICH/GCP and AbbVie policies.

AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and Allergan Aesthetics. They are a global, science-driven pharmaceutical company committed to integrity, innovation, and serving the community.

Brazil

  • Lead the development and execution of clinical development plans for exploratory and biopharmaceutics programs.
  • Oversee global clinical trial operations, including timelines, budgets, vendors, and cross-functional collaboration.
  • Drive risk management and strategic decision-making across the molecule lifecycle.

The hiring company is a pharmaceutical organization focused on clinical development and biopharmaceutics. It values learning agility, innovation, inclusion, and collaboration in a virtual and matrixed environment.

$155,000–$195,000/yr
North America

  • Support planning and operational execution of clinical trials, coordinating across sites, CROs, vendors, and teams.
  • Manage vendor oversight, budgets, timelines, risks, and documentation ensuring GCP compliance.
  • Serve as primary operational contact and mentor junior staff for global Phase 1-3 trials.

Jade Biosciences is a clinical-stage biotechnology company developing best-in-class therapies for autoimmune diseases. It is a small, dynamic company offering an exciting opportunity to contribute to its immunology pipeline.

US Unlimited PTO

  • Collaborate with the Clinical Operations team to support timely conduct of clinical studies according to protocols, GCP, SOPs, and regulations.
  • Lead operational management for assigned regions and sites, including vendor management and oversight of CRO monitors.
  • Contribute to the development and maintenance of study documents and ensure the Trial Master File is complete and inspection-ready.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Founded in 2015, the company has built a portfolio of 20+ drug development programs spanning preclinical to late-stage development across multiple therapeutic areas.

France

  • Monitor and own the progress of clinical studies at investigative sites, ensuring compliance with protocols and regulations.
  • Coordinate study setup activities, including investigator identification and regulatory submissions, while mentoring junior staff.
  • Interact directly with clients, manage payments, and participate in proposal activities, with travel up to 50-60%.

Precision for Medicine is a specialized CRO that combines agility with scientific expertise to support innovative clinical development programs. They foster a collaborative environment that values quality, accountability, and professional development, with a global team of experienced professionals.

$225,000–$240,000/yr
US

  • Support clinical development strategies and study execution across Phase 1-3 programs.
  • Oversee clinical safety and data review, partnering with CROs and internal teams to ensure quality.
  • Contribute to protocols, regulatory documents, and study reports for respiratory disease therapies.

Celea Therapeutics is a biopharmaceutical company dedicated to advancing transformative treatments for serious respiratory diseases, with its lead program in Phase 3 clinical development. As an early-stage, mission-driven team, Celea values accountability, transparency, collaboration, innovation, and passion.

$120,300–$222,600/yr
US

  • Oversee EMEA clinical trial operations, partnering with CROs and sites to ensure compliance and timely execution.
  • Lead regional regulatory submission strategies and proactively resolve operational challenges to maintain study timelines.
  • Mentor junior team members, review data and TMF documentation, and provide regular study updates to stakeholders.

Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on developing transformative treatments for metabolic diseases. The company fosters a collaborative culture of problem solvers dedicated to bringing bold scientific approaches to patients.

$146,000–$161,000/yr
US

  • Lead and oversee clinical data management activities across assigned studies, ensuring high-quality data in compliance with ICH-GCP and company SOPs.
  • Manage CROs and external vendors, including database start-up, data cleaning, and database lock, while maintaining quality, timelines, and budget.
  • Collaborate cross-functionally with Biometrics, Clinical Operations, Medical, and other teams to drive data management milestones and inspection readiness.

We are developing novel biologics designed to set a new standard for the treatment of chronic skin diseases like plaque psoriasis. As a Nasdaq-listed startup, we foster a vibrant, inclusive culture where everyone is encouraged to bring their authentic selves to work.

Spain

  • Monitor clinical investigative sites to ensure protocol execution and regulatory compliance.
  • Conduct site qualification, initiation, interim monitoring, and closeout visits for Phase 1-4 studies.
  • Train site personnel, manage investigator payments, and identify new investigators and sites.

AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, and neuroscience. It is a global biopharmaceutical company committed to integrity, innovation, and transforming lives.

$90,000–$110,000/yr
US

  • Lead planning, execution, and integrated governance for Future of Medicine initiatives across Clinical Conduct, Quality, Technology, and Operations.
  • Translate clinical, operational, quality, and program needs into scalable workflows, requirements, SOPs, and training.
  • Drive readiness, change planning, and sustained adoption of new program requirements and technology capabilities.

Care Access brings world-class clinical research and health services to communities facing barriers to care through hundreds of research locations, mobile clinics, and global clinicians. The company values an inclusive culture where diverse backgrounds are welcomed and people are at the heart of medical progress.

$137,300–$242,300/yr
US

  • Lead clinical study strategy and execution for regulatory approvals and evidence initiatives.
  • Partner with stakeholders, investigators, and KOLs to design protocols and manage study progress.
  • Oversee monitoring, compliance, and data analysis while mentoring junior staff.

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, known for da Vinci and Ion systems. Its team of engineers, clinicians, and innovators works to make surgery smarter, safer, and more human.

$150,000–$150,000/yr
US Unlimited PTO

  • Own the Clinical Ops quarterly roadmap, turning priorities into a clear plan with visible progress.
  • Build the escalation playbook, licensing/credentialing prioritization, and SOP library to scale clinical operations.
  • Partner cross-functionally with clinical, product, and leadership on expansion, efficiency, and automation initiatives.

Hey Jane provides safe, discreet virtual reproductive and sexual health care, including medication abortion, through an in-house clinical team. We are the first and largest virtual medication abortion provider in the US, having cared for roughly 150,000 patients across 23+ states.

Poland

  • Lead full service clinical projects in Oncology, ensuring timelines, budget, and quality.
  • Serve as primary client liaison and coordinate cross-functional teams across all study stages.
  • Manage all aspects of clinical trials, including proposal strategy, documentation, and reporting.

Precision for Medicine is a CRO enabling precision medicine through novel clinical trial designs, biomarker and data analytics, and a focus on rare diseases and oncology. We are a supportive, collaborative team that values work life balance and development.

  • Provide clinical, scientific, and strategic expertise to drug development programs from lead compound identification to launch.
  • Lead execution of clinical development plans, including trial documents, regulatory interactions, and cross-functional alignment.
  • Establish and maintain relationships with external medical experts and represent Ipsen at investigator meetings and scientific conferences.

Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With teams in more than 40 countries, it champions human-centric leadership and fosters a culture of collaboration, excellence and impact.

France

  • Oversee GCP compliance, manage deviations and CAPAs, and conduct quality and TMF reviews.
  • Maintain inspection readiness and support CRO oversight per ICH E6(R3).
  • Collaborate with Data and Clinical teams to embed compliance into workflows and train teams.

Resilience Care is a French medtech founded in 2021, offering AI remote monitoring for oncology, gastroenterology, and psychiatry. It serves 35,000 patients across 200+ facilities with an agile, collaborative culture.