Source Job

• Lead end-to-end clinical data review activities across complex trials, ensuring data accuracy and quality for analysis.
• Serve as primary contact for internal and external stakeholders, managing timelines, budgets, and resources.
• Mentor junior team members and provide subject matter expertise in clinical data science and analytics.

• Ensure operational efficiency and excellence in clinical data management services.
• Manage team performance, budgeting, and process improvements.
• Collaborate with stakeholders to optimize data management technology and standards.

Alimentiv is a clinical research organization specializing in data management services for clinical trials. The company has a global presence and emphasizes operational excellence, team leadership, and regulatory compliance.

• Oversee day-to-day operations of clinical trials, ensuring compliance with GCP, FDA, and ICH guidelines while managing CROs and vendors.
• Serve as primary point of contact for CROs and trial vendors, tracking performance metrics, budgets, and timelines to ensure project success.
• Collaborate with cross-functional teams to prioritize data integrity, participant safety, and quality control, with travel required up to 30%.

Peptilogics is a surgical therapeutics company dedicated to curing and preventing medical device-related infections. They are a clinical-stage biotech with a small, agile team and a culture of proactive, independent thinking.

• Serve as primary contact for data management timelines, deliverables, and technical issues across clinical projects.
• Oversee database design, UAT testing, data validation, and quality reviews to ensure compliance.
• Train study teams, manage project resources, and support audits and bid defense meetings.

The company is a partner firm managing clinical data for life sciences research. They foster a collaborative, quality-focused culture and support professional development.

• Manage day-to-day clinical trial operations, including CRO/vendor oversight and site management.
• Lead cross-functional study teams, develop study documents, and implement risk mitigation strategies.
• Ensure high-quality deliverables within timelines and budget, from start-up through close-out.

Ultragenyx is a biopharmaceutical company dedicated to developing life-changing treatments for rare diseases. They foster a supportive and inclusive culture focused on learning and growth, with a global team committed to innovation.

• Lead the development and optimization of clinical data systems across global trials.
• Drive data standardization and build scalable validation frameworks to ensure data integrity.
• Act as a strategic liaison between clinical, biostatistics, and regulatory teams to translate requirements into technical solutions.

Precision Medicine Group is a global life sciences company focused on precision medicine and clinical research solutions. The company fosters a collaborative and compliance-oriented culture with a diverse team of professionals.

• Prepare and maintain Trial Master Files for internal and external studies to meet sponsor specifications.
• Communicate with sponsors, project managers, and study contacts to ensure compliance with protocols and regulatory requirements.
• Manage multiple priorities and ensure file structure and indexing are accurate.

Celerion is a clinical research organization that uses translational medicine to accelerate drug development. The company values integrity, trust, teamwork, and respect, and is an equal opportunity employer.

• Oversee strategic planning and execution of global clinical studies.
• Manage internal and external resources, including CROs, to ensure quality and compliance.
• Lead cross-functional teams and contribute to trial design and budgeting.

Dianthus Therapeutics is a clinical-stage biotechnology company developing novel therapies for severe autoimmune diseases. The company values a culture centered on core principles and aims to elevate patient care.

• Provide study oversight as the primary liaison between CRAs, site staff, clients, and vendors across all study stages.
• Ensure clinical monitoring activities comply with SOPs, regulations, GCPs, and study-specific requirements.
• Support team training, review site visit reports, and manage oversight of the Trial Master File and eTMF.

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) trusted since 1996, delivering ethical services to pharmaceutical, biotech, and medical device companies. They foster a collaborative community where team members feel valued and empowered to make a meaningful impact on global health.

• Leads and oversees global clinical trials from inception through closure, ensuring quality and efficiency.
• Manages external vendors, recruitment strategies, and cross-functional team coordination.
• Maintains inspection readiness and contributes to risk management and process improvement.

AbbVie discovers and delivers innovative medicines and solutions for serious health issues across immunology, oncology, and neuroscience. The company is a global biopharmaceutical leader with a focus on making a remarkable impact.

• Serve as the primary point of contact for assigned protocols, linking Country Operations with the clinical trial team.
• Manage project timelines, deliverables, and performance for clinical studies from feasibility to close out.
• Ensure compliance with ICH/GCP, country regulations, and company policies while leading local study teams.

Merck is a global healthcare leader with a diverse range of prescription medicines, vaccines, and animal health products. With over 100 years of history, the company employs tens of thousands worldwide and fosters a culture of innovation and inclusivity.

• We oversee a team of Clinical Research Project Managers delivering clinical studies and observational research programs.
• We shape team performance, resource strategy, operational excellence, and talent development across a diverse project portfolio.
• We ensure delivery against scope, timelines, budgets, quality standards, client expectations, and business objectives.

Jobgether uses AI-powered matching to connect candidates with hiring companies. This position is listed on behalf of a partner company that manages all applications, and the role is within a clinical research organization focused on delivering clinical studies and observational research programs.

• Leads quality compliance, risk management, and vendor oversight programs to support late-stage development.
• Manages inspection readiness, data integrity assessments, and regulatory authority interactions across GxP.
• Provides senior-level quality judgment and drives risk-based decisions in a dynamic environment.

Braveheart Bio is a clinical-stage biopharmaceutical company developing therapies for hypertrophic cardiomyopathy and other cardiovascular diseases. It has a proven leadership team, strong financial foundation, and a high-value late-stage asset, offering an opportunity for mission-driven professionals.

• Independently manages significant aspects of clinical trials and research projects.
• Trains and provides guidance to less experienced staff, and oversees data management.
• Ensures compliance with regulations, monitors IRB submissions, and interfaces with study sponsors.

Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate and prepare leaders for the future. The university is committed to diversity and inclusion, providing a supportive environment for staff and faculty.

• Lead clinical data system projects from initiation to closeout, ensuring alignment of timelines and deliverables.
• Serve as key contact for internal and external teams, facilitating communication and coordination.
• Support business development activities and quality reviews to maintain high standards.

Our partner is a company that provides clinical trial data systems and services. They operate in an international, collaborative environment focused on clinical research and innovation.

• Prepare and ensure completeness of Trial Master Files for internal and external studies.
• Maintain the Trial Master File, creating file structure and indexing contents.
• Communicate with client sponsors, project managers, monitors, and sites to ensure compliance.

Celerion is a performance-driven drug research company operating in the clinical research industry. They focus on integrity, trust, teamwork, and respect, offering a strong developmental environment.

• Manage execution of study-level activities, including creating trial documents and overseeing vendor delivery and budgets.
• Coordinate country and regional trial management, aligning feasibility strategies and mitigating local risks.
• Support program-level compound training and mentor new team members in Trial Management.

Johnson & Johnson is a global healthcare innovator focused on preventing, treating, and curing complex diseases through Innovative Medicine and MedTech. With a large workforce, they emphasize an inclusive work environment guided by their Credo, respecting diversity and dignity.

• Support operational execution of clinical studies from initial synopsis through final deliverables.
• Manage implementation, on-time execution, and conduct of clinical studies, including budget and vendor management.
• Oversee cross-functional study teams and ensure compliance with regulations and data integrity.

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy.

• Act as a trusted advisor to customers and clinical sites, ensuring trial designs meet goals and providing training.
• Lead database development activities, configure forms and rules in Vault CDMS, and build custom SQL listings.
• Support requirements gathering, user acceptance testing, and risk management to keep projects compliant.

Veeva Systems is a mission-driven pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies, it surpassed $3B in revenue and is a public benefit corporation committed to balancing stakeholder interests.