Serve as a subject matter expert for site management and monitoring strategies across complex clinical studies.
Collaborate with clinical teams, investigators, and stakeholders to ensure compliance, data quality, and trial success.
Mentor CRA staff, resolve escalated issues, and support site qualification, initiation, monitoring, and close-out visits.
Jobgether is a platform that uses AI-powered matching to connect candidates with job opportunities. They operate as a global healthcare and technology environment, offering professional growth and innovative solutions.
Serve as the primary point of contact and partner with investigative sites to ensure high-quality clinical trial conduct.
Conduct site evaluation, training, monitoring, and closure activities in compliance with regulations, GCPs, and SOPs.
Utilize risk-based monitoring and site engagement strategies to improve data integrity, compliance, and study performance.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics. A large global biopharmaceutical company, AbbVie fosters a culture of innovation and integrity to transform patients' lives.
Acts as primary point of contact for investigative sites, providing training and support to ensure compliance with protocols and regulations.
Conducts site evaluation, monitoring, and closure activities while managing recruitment and retention plans based on patient journey.
Collaborates with central monitoring to assess risks and ensure data quality, safety reporting, and audit readiness at assigned sites.
AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, and neuroscience. It is a large pharmaceutical company with a global presence and a culture focused on remarkable impact.
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.
Provide therapeutic and operational leadership throughout the clinical program and project delivery lifecycle.
Collaborate with cross-functional teams to develop effective delivery strategies and resolve operational challenges.
Ensure clinical projects within the assigned franchise are appropriately resourced and aligned with operational goals.
Our partner is a global clinical research organization dedicated to advancing healthcare innovation and improving patient outcomes through high-quality clinical trials. They offer a collaborative and inclusive environment with experienced professionals across global therapeutic and operational teams, focusing on professional growth and meaningful impact.
Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.
Serve as primary point-of-contact and escalation point for clients, coordinating all functional services and external vendors.
Manage study budgets, project profitability, and billing compliance to ensure financial health and alignment with scope.
Develop robust project plans, track metrics, and prepare status updates for clients and senior management.
Precision Medicine Group is a global contract research organization specializing in oncology and precision medicine. The company values collaboration and quality, employing a diverse team of professionals dedicated to advancing clinical research.
Serves as clinical trial lead, overseeing study planning, conduct, and oversight per protocol and regulations.
Develops study documents, manages site feasibility, and drives recruitment strategies.
Leads internal clinical team meetings and ensures quality deliverables through metric reporting.
Precision Medicine Group is a life sciences company that supports clinical research and development. The company is large enough to offer a range of benefits and emphasizes a collaborative, ethical culture focused on quality and compliance.
Lead clinical trial support services and site engagement strategy to maximize patient participation.
Orchestrate cross-functional teams to translate partner needs into scalable, data-driven programs.
Act as principal medical point of contact for pharma partners, driving contract negotiation and patient impact.
Natera is a global leader in cell-free DNA testing, dedicated to oncology, women's health, and organ health. The Natera team consists of highly dedicated professionals from world-class institutions, who care deeply for our 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.
Act as the primary customer contact, providing clinical knowledge of Amgen's oncology products and communicating clinical and economic benefits to medical professionals.
Create and execute comprehensive territory plans including branded sales messages, medical educational programs, and achieving sales targets.
Partner with colleagues to share best practices and continuously learn to grow as a Senior Oncology Specialist.
Amgen is a biotechnology pioneer dedicated to serving patients with serious illnesses by discovering and delivering innovative medicines. Founded in 1980, it has grown into one of the world's leading independent biotechnology companies, reaching millions of patients globally.
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.
Build and lead the US Field Medical Affairs organization, including hiring and managing a high-performing MSL team.
Implement field strategy in alignment with clinical development and launch plans, and oversee MSL training and analytics.
Collaborate internally and externally, track KPIs, and ensure compliance with regulations while engaging key opinion leaders.
The job posting states: 'Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.'
Manage a portfolio of strategic alliance partnerships, overseeing customer relationships, contractual commitments, retention, growth opportunities, and overall satisfaction.
Build and maintain strong executive-level relationships through regular communication, business reviews, strategic discussions, and performance updates.
Coordinate cross-functional teams to deliver customer programs, resolve challenges, and achieve agreed business objectives.
Our partner is a global life sciences organization focused on advancing healthcare and biotechnology. They offer a collaborative international environment with opportunities for professional growth.
You will monitor and own the progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
You will coordinate all activities to set up and monitor a study, including identifying investigators and preparing regulatory submissions.
You will travel domestically up to 50-60% for site visits and maintain fluency in English and local language.
Precision for Medicine is a clinical research organization focused on precision medicine for oncology and rare diseases. They are a smaller CRO with a strong culture and high employee retention.
Serve as the primary relationship manager for strategic external oncology alliances to build long-term collaborations.
Own the high-level tracking and overview of incoming studies, ensuring alignment with clinical priorities.
Lead legal coordination and contract management with external partners, ensuring compliance and value.
Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. The Natera team consists of highly dedicated professionals from world-class institutions who care deeply about their work and each other.
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.
Review, draft, negotiate, and track legal agreements including clinical trial agreements (CTA), confidentiality disclosure agreements (CDA), and site budgets.
Lead interactions with internal study teams, sites, and sponsors across North America and Europe to resolve contractual issues and ensure alignment with timelines.
Maintain contract files and databases, coordinate execution, and update stakeholders on negotiation status.
Precision Medicine Group is a precision medicine company that supports clinical research and drug development. The company offers a collaborative culture and is an equal opportunity employer with a focus on innovation and service.
Act as a strategic partner for key customers, leading governance, growth initiatives, financial performance, and cross-functional collaboration.
Lead and oversee global, multiregional, or complex regional Clinical FSP partnerships, ensuring alignment with contractual agreements and strategic priorities.
Provide executive oversight for clinical FSP delivery, ensuring quality, timelines, key performance indicators, and contractual commitments are achieved.
The employer is a global clinical research organization that partners with pharmaceutical and biotech companies to deliver clinical trials. They are a large, established company with a culture focused on innovation, collaboration, and advancing healthcare worldwide.