The Clinical Biomarker Specimen Specialist manages the lifecycle of clinical trial specimens from collection through testing and final disposition. They collaborate with internal stakeholders and vendors to ensure compliance with protocols and maintain accurate chain of custody.
The role involves preparing, compiling, and submitting regulatory applications to INVIMA while managing the lifecycle of pharmaceutical products. You will also coordinate cross-functional contributions and ensure compliance with local regulatory requirements and timelines.
The Senior Study Manager provides operational leadership for end-to-end clinical trial delivery, ensuring projects are completed on time, within budget, and in compliance with regulations. They lead cross-functional teams, manage vendor performance, and proactively identify and mitigate risks throughout the trial lifecycle.
Monitor clinical trial sites through on-site and remote visits while ensuring high-quality execution and compliance. Collaborate with cross-functional teams to maintain study integrity and build strong relationships with investigators and site staff.
The Principal Solutions Consultant will design innovative, client-centric Functional Service Provider (FSP) solutions to drive new business and growth. They will lead cross-functional teams to develop competitive bid strategies, define operating models, and ensure the successful delivery of high-impact clinical development solutions.
The specialist will identify and engage pediatric migraine study sites across Europe to support feasibility, startup, and enrollment activities. They will also manage investigator relationships and implement strategies to address recruitment barriers and improve site performance.
The Clinical Research Associate is responsible for monitoring clinical trial sites to ensure compliance with protocols and regulatory requirements. They will oversee data collection and maintain accurate documentation throughout the clinical study process.
The Principal Medical Writer will lead the development of high-quality clinical and regulatory documents, including CSRs, IBs, and ICFs. They will also manage complex projects, mentor colleagues, and build strong relationships with clients and cross-functional teams.
The Regulatory Affairs Associate supports local regulatory activities including market authorizations, product registrations, and control changes in compliance with ANVISA requirements. They are responsible for preparing submissions, maintaining regulatory records, and monitoring regulatory updates to ensure ongoing compliance.
The Study Start-Up Specialist coordinates site activation activities, including regulatory submissions, contract management, and the preparation of essential clinical trial documents. They also identify and resolve site-related risks while collaborating with cross-functional teams to ensure project timelines and quality standards are met.
The Vice President of Regulatory Science leads high-impact client engagements and provides advanced regulatory and scientific consulting services. They are responsible for managing project teams, developing business solutions, and acting as a trusted advisor to clients throughout the product lifecycle.
The Senior/Vice President of Regulatory Science will lead strategic regulatory initiatives and provide expert guidance to biopharma clients throughout the product lifecycle. They are responsible for managing complex projects, mentoring junior staff, and driving business development through thought leadership and industry engagement.
The Global Study Associate supports the Clinical Trial Manager in managing clinical study activities, including site feasibility, start-up, maintenance, and close-out. They are responsible for ensuring GCP compliance, overseeing vendor activities, and maintaining the Trial Master File.
The Global Study Associate supports the Clinical Trial Manager in managing clinical study activities, including site feasibility, start-up, maintenance, and close-out. They are responsible for ensuring GCP and SOP compliance, overseeing vendor activities, and maintaining the Trial Master File.
The Clinical Trial Manager will lead local study delivery, oversee operational execution, and ensure compliance with regulations, quality standards, and budgets. They will collaborate with cross-functional teams to drive study performance and manage regulatory and ethics submissions.
The role involves managing local regulatory operations, including product registrations, lifecycle management, and ensuring compliance with health authority requirements. You will serve as a key liaison between internal stakeholders and health authorities to support the delivery of therapies.
The Biostatistician II will contribute to clinical trial design, protocol development, and the production of statistical analysis plans and reports. They will also coordinate project teams, interact with clients, and ensure the quality of derived datasets and statistical outputs.
The Investigator Contracts Lead is responsible for negotiating clinical study agreements and site budgets while managing risks and timelines. They collaborate with internal legal, finance, and clinical teams to ensure compliance and operational efficiency across global sites.
The Scientific Specialist is responsible for developing high-quality scientific content and managing project delivery to meet client objectives and timelines. They will also provide mentorship to team members and foster strong relationships with external opinion leaders and clients.
The Senior Clinical Research Associate will oversee monitoring activities at investigator sites to ensure clinical trial quality, data integrity, and regulatory compliance. They will collaborate with site personnel and project teams to manage protocol adherence and support the successful delivery of oncology clinical trials.
The specialist will drive the adoption of AI-enabled tools and commercial technologies to improve sales effectiveness. They will act as a bridge between the commercial team and technical departments to define requirements, test solutions, and provide ongoing user support.
Lead project teams and manage the day-to-day operations of global clinical trials for biotech clients. Deliver studies on time, within budget, and to high quality standards while aiming to exceed client expectations.
The Senior Clinical Research Associate is responsible for managing investigator sites, ensuring patient safety, and maintaining compliance with GCP and study protocols. They oversee site monitoring, recruitment support, and the resolution of protocol-related issues throughout the clinical trial lifecycle.
The Project Manager will lead cross-functional teams to execute early phase clinical trials while maintaining compliance with regulatory standards and internal SOPs. They are responsible for managing sponsor relationships, project financials, study timelines, and ensuring high-quality delivery within budget.
The Senior Solution Enablement Lead acts as the primary point of contact for business solutions, ensuring technology and processes align with business strategy to maximize ROI. They collaborate with stakeholders, vendors, and IT teams to manage solution backlogs, formulate long-term roadmaps, and oversee the implementation of new features.
Provide quality oversight for technology solution development, validation, and maintenance to ensure compliance with GxP and regulatory standards. Facilitate root cause analysis, manage CAPA activities, and support internal and external audits as a subject matter expert.
The Senior Scientific Specialist will act as a senior therapy area expert, leading the delivery of assigned programs and projects. They are responsible for developing high-quality scientific content, mentoring team members, and ensuring compliance with departmental procedures.
The manager will lead the end-to-end proposal and contract process for Early Phase clinical research programs, coordinating across internal departments to deliver accurate client materials. They are responsible for developing budgets, negotiating terms, and ensuring all documentation aligns with client specifications and internal policies.
The consultant will manage regulatory affairs activities, specifically focusing on clinical trial applications and project execution within a team environment. They will also serve as a primary client contact, ensuring project quality, financial accuracy, and the delivery of consulting services.
The Clinical Data Associate II will lead or co-lead data management activities for clinical studies, ensuring high-quality data collection and regulatory compliance. They will collaborate with cross-functional teams to manage EDC systems, perform data reconciliation, and support database lock activities.
