Source Job

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
• Collaborating with investigators and site staff to facilitate smooth study conduct.

ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of new medicines and treatments. As a values-driven company, ICON fosters a culture of integrity, collaboration, agility, and inclusion, employing a diverse workforce.

• Serve as the primary liaison for investigator sites, conducting monitoring activities including initiation, routine visits, and close-out while ensuring ICH-GCP compliance.
• Support site activation, recruitment, and enrollment, oversee adverse event reporting, and maintain accurate study documentation.
• Manage investigational product handling, develop corrective actions for site issues, and participate in audit readiness activities.

Jobgether is a platform that uses AI-powered matching to connect candidates with clinical research roles. The company evaluates applications objectively and shares top candidates with hiring partners, focusing on improving patient access to innovative therapies.

• Manage a team of 15-17 Study Management Associates (SMAs) to deliver best-in-class study execution.
• Drive performance management, mentoring, and professional development for direct reports.
• Support resource management, adherence to regulations, and continuous process improvements.

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. The company operates across several therapeutic areas including immunology, oncology, and neuroscience, with a significant global presence and a culture focused on innovation and impact.

• Manage all aspects of clinical trials from start-up through close-out, ensuring timelines, costs, and quality metrics are met.
• Oversee vendor/CRO selection and management, study contracting, budgeting, and forecasting.
• Lead study-related activities including protocol preparation, investigator selection, and training, and collaborate with cross-functional teams.

Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.

• Manage and oversee all clinical aspects of trials across multiple countries, ensuring timeline adherence, quality, and scope.
• Lead CRAs and collaborate with cross-functional teams to achieve high client satisfaction and smooth trial operations.
• Identify risks, develop creative action plans, and maintain focus on study priorities through effective communication.

Precision for Medicine is a precision medicine CRO that combines novel trial designs, advanced biomarker analytics, and deep oncology expertise to accelerate drug development. The company fosters a dynamic, high-energy culture and values dedicated professionals who thrive in challenging environments.

• Conduct and report SIV, RMV, COV onsite monitoring visits and perform CRF review, source document verification, and query resolution.
• Manage site communication and be the point of contact for in-house support services and vendors, while communicating with internal project teams on study progress.
• Support regulatory teams in preparing documents for study submissions and prepare for and participate in audits and inspections.

The company is a dynamic, global mid-size clinical research organization founded in 1995, bringing together more than 3,000 dedicated individuals. They work on the frontline of medical science, changing lives and bringing new medicines to those who need them.

• Manage and deliver full clinical site monitoring services for complex multinational projects, ensuring compliance with SOPs, study guidelines, and GCP best practices.
• Act as Lead CRA, serving as primary liaison between CRAs and project teams, and participate in development of monitoring plans, protocols, and tools.
• Identify and recruit site investigators, oversee investigational site monitoring, and ensure site staff are compliant with training requirements.

Alimentiv is a clinical research organization providing monitoring and site management services for clinical trials. They are a full-time, permanent employer with a focus on building collaborative relationships and maintaining high standards in clinical study delivery.

• Accountable for leading assigned clinical research activities and partnering with stakeholders on study design.
• Conducts on-site and remote site visits, including qualification, initiation, monitoring, and close-out.
• Tracks study progress, manages budgets, and mentors junior clinical study managers.

Intuitive is a pioneer and market leader in robotic-assisted surgery, dedicated to minimally invasive care. With over 25 years of experience, the company fosters an inclusive and diverse team culture where employees are empowered to do their best work.

• Conduct qualification, initiation, interim, and close-out monitoring visits (on-site and remote) in compliance with GCP, ICH, and SOPs.
• Build and maintain strong relationships with investigator sites, providing training and guidance to ensure study quality.
• Support IRB submissions, regulatory documentation, and trial master file quality across clinical programs.

CoMind develops non-invasive neuromonitoring technology for clinical brain monitoring. The company is a cutting-edge startup focused on improving diagnosis and treatment of brain disorders, with a culture that embraces AI in daily work.

• Lead and manage the clinical operations team, setting and executing departmental strategy.
• Oversee clinical trial agreements, budgets, expenditures, and ensure timely execution of clinical programs.
• Establish and maintain good working relationships with clinical study site personnel and oversee study conduct.

Iovance Biotherapeutics is a biotechnology company focused on developing tumor infiltrating lymphocyte (TIL) therapy for cancer. The company is pioneering a transformational approach to treating cancer and is committed to continuous innovation in cell therapy, including gene-edited cell therapy.

• Lead and oversee clinical monitoring activities for Phase 1–3 global trials.
• Establish CRO oversight, manage vendor performance, and ensure compliance with ICH-GCP.
• Build scalable monitoring infrastructure, develop SOPs, and drive continuous improvement.

Oruka Therapeutics develops novel biologics for chronic skin diseases like plaque psoriasis. They are an emerging biotech company building a core team with a focus on establishing an engaged, inclusive, and positive culture.

• Serve as primary contact for assigned study sites, ensuring protocol implementation and compliance with ICH-GCP and local regulations.
• Conduct on-site and remote monitoring visits, building strong relationships with site staff and resolving operational issues.
• Maintain inspection readiness of sites, manage study documentation, and contribute to study performance tracking and recruitment support.

Our partner is a clinical research organization that manages global clinical trials. They offer a collaborative global team environment and opportunities for career development in clinical operations.

• Leads writing and preparing clinical and regulatory documents for drug and device development.
• Coordinates review, approval, and quality control across functions to ensure compliance and timelines.
• Develops knowledge of US and international regulations and participates in process improvements.

AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, neuroscience, and aesthetics. They are a large global biopharmaceutical company committed to having a remarkable impact on people's lives.

• Lead global regulatory strategy for one or more drug development programs, with emphasis on submissions and health authority interactions.
• Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments, ensuring high-quality documents.
• Collaborate with cross-functional teams to create and negotiate clinical-regulatory development paths and prepare for health authority meetings.

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, including gene-edited cell therapy, which may be a promising option for patients with cancer.

• Partner with subject matter experts to assess training needs and design effective learning solutions across translational sciences, clinical operations, and regulatory compliance.
• Coordinate new hire onboarding and maintain training documentation, records, and reporting in accordance with regulatory expectations.
• Manage learning platforms, deliver instructor-led and e-learning programs, and serve as primary intake point for training requests.

Precision for Medicine is a global precision medicine clinical research services organization that integrates clinical operations, laboratory expertise, and advanced data sciences to improve clinical research and development. The company focuses on trials from early development through approval, with embedded experience in oncology and rare disease, and operates as part of Precision Medicine Group.

• Reviews patient data for Phase I-IV clinical research and non-interventional studies to ensure compliance with protocols and regulatory requirements.
• Communicates and escalates serious issues to the project team and develops action plans as needed.
• Maintains working knowledge of ICH/GCP guidelines and company SOPs, documenting activities per project requirements.

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We are a global company with over 29,000 employees, dedicated to developing our people and building an inclusive culture.

• Facilitate negotiations of site agreements and budgets to align with site activation plans.
• Customize and prepare country- and site-specific agreements, organizing translations.
• Track the status of site agreement and budget negotiation, prepare executable versions, and coordinate the signature process.

PSI is a global company founded in 1995 that brings new medicines to those who need them, working on the front line of medical science. They bring together more than 3,000 driven, dedicated, and passionate individuals who care for staff, clients, partners, and quality of work.

• Lead programming activities for oncology clinical trials, developing and validating SDTM and ADaM datasets following CDISC standards.
• Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and regulatory submissions.
• Collaborate with Biostatistics, Data Management, and Regulatory Affairs to ensure compliance with FDA, EMA, and PMDA requirements.

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 28 years of experience, they employ more than 4,000 professionals across 20+ countries, fostering a culture of diversity and continuous training.

• Lead execution of RBQM strategy across complex clinical trials, including risk assessments and monitoring plans.
• Partner with cross-functional teams and CROs to identify, track, and mitigate risks proactively.
• Ensure compliance with global regulations, drive process improvements, and report KRIs to leadership.

Deciphera is a biopharmaceutical company focused on developing kinase inhibitor therapies for cancer. The company offers a competitive compensation package and promotes a culture of personal and professional growth.