Associate Director, Clinical Trial Quality Oversight, Site Monitoring

Menarini Group; Italia; Remoto; EUR 80.000 - 110.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking an Associate Director, Clinical Trial Quality Oversight. This remote role involves ensuring the quality and compliance of clinical trials, particularly within Europe. The candidate will develop monitoring oversight plans, evaluate monitoring activities, and collaborate with various stakeholders to guarantee patient safety and data integrity. A strong background in clinical trial monitoring and quality assurance is essential for this position.

Competenze

• Minimum of 8-10 years of experience in clinical trial monitoring or quality assurance.
• Demonstrated experience in overseeing site monitoring activities.
• In-depth knowledge of ICH GCP guidelines and European regulations.

Mansioni

• Develop and implement site monitoring oversight plans.
• Conduct quality evaluations of monitoring activities.
• Collaborate with internal stakeholders for unified quality management.

Conoscenze

Clinical trial monitoring

Quality assurance

Risk management

Analytical skills

Communication

Interpersonal skills

Formazione

Bachelor's degree in life sciences

Strumenti

Clinical trial management systems (CTMS)

Electronic data capture (EDC) systems

Trial Master File (TMF) systems

Descrizione del lavoro

Overview

Associate Director, Clinical Trial Quality Oversight

Location: Europe, remote

Are you passionate about ensuring the highest standards of quality and compliance in clinical trials? Do you have a keen eye for detail and a commitment to patient safety and data integrity? Are you ready to lead and innovate in the field of clinical trial quality oversight? If so, we invite you to join our dynamic team!

Responsibilities

About the Role:

We are seeking a highly motivated and experienced Associate Director, Clinical Trial Quality Oversight to join our clinical operations team. This critical role will be responsible for ensuring the highest standards of quality and compliance in the conduct of clinical trials, particularly within our European operations, through expert oversight of site monitoring activities. The primary focus will be on safeguarding patient safety and ensuring the integrity, accuracy, and reliability of clinical trial data, in accordance with ICH Good Clinical Practice (GCP), European regulatory requirements, and internal Standard Operating Procedures (SOPs). You will work closely with internal study teams, Clinical Research Organizations (CROs), and investigational sites to proactively identify and mitigate risks, assess monitoring performance, and drive continuous improvement in monitoring processes.

Responsibilities:

• Develop and implement comprehensive site monitoring oversight plans aligned with study protocols, risk assessments, and regulatory requirements.
• Provide strategic direction and guidance to internal monitoring teams and/or CRO monitors to ensure adherence to monitoring plans and quality standards.
• Conduct quality evaluations of monitoring activities through various methods, including review of monitoring reports, key performance indicators (KPIs), central monitoring data, and co-monitoring visits (remote or on-site as needed).
• Assess site performance and compliance with the protocol, GCP, and applicable regulations, focusing on aspects critical to patient safety and data integrity.
• Identify, document, and escalate potential systemic issues or significant non-compliance observed during oversight activities.
• Collaborate with internal stakeholders (e.g., Clinical Operations, Data Management, Medical Affairs, Quality Assurance) to ensure a unified approach to quality and risk management.
• Serve as a subject matter expert on monitoring best practices, GCP, and regulatory requirements for the clinical trial teams.

Qualifications

Qualifications:

• Bachelor's degree in life sciences, healthcare, or a related field.
• Minimum of 8-10 years of experience in clinical trial monitoring and/or clinical quality assurance roles. Oncology experience is required.
• Demonstrated experience in overseeing site monitoring activities, either as a Lead CRA, Clinical Team Lead, or in a dedicated oversight role.
• In-depth knowledge of ICH GCP guidelines, European (EMA) regulations, FDA regulations, and other applicable regulatory requirements for clinical trials.
• Strong understanding of clinical trial processes from study start-up to close-out.
• Experience with risk-based monitoring methodologies and central monitoring approaches.
• Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and Trial Master File (TMF) systems.
• Ability to travel as required (domestic and/or international)

As a person, you will possess proven ability to identify and assess potential risks to patient safety and data integrity. You will also have excellent analytical skills with the ability to review and interpret complex clinical data and monitoring reports. Strong communication, interpersonal, and negotiation skills are essential, with the ability to effectively collaborate with internal and external stakeholders. You should be able to work independently, prioritize tasks, and manage multiple projects simultaneously.

Preferred Qualifications:

• Advanced degree (Master's, PharmD, PhD) in a related field.
• Experience in a quality assurance or audit role within the pharmaceutical or biotechnology industry.
• Certification in clinical research (e.g., CCRP, CCRA).

Elevate Your Impact:

If you are a passionate and skilled project management professional seeking a challenging and rewarding opportunity to contribute to the advancement of oncology treatments, we encourage you to apply. Join us and be a part of a team that is making a difference in the lives of patients.

Menarini Stemline is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees

The Company

Founded in 1886 in Naples under the name of Farmacia Internazionale, Menarini moved in 1915 to Florence where the Group’s headquarters are still located today. High quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. These five pillars form the foundation of the Menarini Group, an Italian pharmaceutical company with nearly 135 years of history.

The Menarini Group is present in 70 countries and our products are sold in 140 locations around the world. Its companies span from Europe to Asia, to Africa and the Middle East, to Central America and to the United States where with the acquisition of Stemline Therapeutics, a NASDAQ-listed biopharmaceutical company, the company marked its entry into the US oncology market.

Thanks to the valuable contribution of around 18,000 employees, every year more than 500 million packs of drugs are produced at the Group's 18 manufacturing sites including a biotech plant for the manufacturing of monoclonal antibodies that also serves external clients distributed across 6 continents.

Menarini has made a strong commitment to oncology, investing in a pipeline of five investigational compounds for the treatment of a variety of haematological and solid tumours. The acquisition of Stemline Therapeutics in June 2020, further strengthened Menarini’s oncology portfolio, adding both commercial and clinical-stage assets. Tagraxofusp is a novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and to date, the only approved treatment for BPDCN in the U.S. and EU, and the first and only approved CD123-targeted therapy. Tagraxofusp is also being evaluated as both a single agent and in combination, in other CD123+ indications, including acute myeloid leukaemia (AML), chronic myelomonocytic leukaemia (CMML), and myelofibrosis (MF).

Additionally, Menarini received exclusive rights to commercialise Selinexor for the treatment of oncology indications in the European Union and other European countries (including the United Kingdom), Latin America and other key countries. Menarini has signed an exclusive licensing agreement with Karyopharm Therapeutics for the rights to commercialise an innovative therapeutic option in Europe, Latin America, Turkey, Russia, and CIS countries. Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear export compound for the treatment of hematologic cancers and solid tumours. It is already marketed in the US for multiple myeloma and is under development for solid tumour indications. Selinexor is registered in the EU for both early and late lines.

Menarini entered into a global licence agreement with Radius Health to complete the development of Elacestrant, an oral SERD in late-stage Phase 3 development for hormone receptor-positive advanced breast cancer. Following a successful phase 3 study, Menarini Stemline received FDA approval in January 2023 under priority review and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively in September 2023.

Menarini’s commitment to oncology is also reflected in the investments made in the liquid biopsy diagnostic field through its affiliate Menarini Silicon Biosystems (MSB), a pioneer in rare cell analysis and non-invasive, advanced diagnostic solutions. MSB’s CELLSEARCH Circulating Tumour Cell (CTC) Test is the first and only clinically validated blood test cleared by the U.S. Food & Drug Administration (FDA) for detecting and counting CTCs in metastatic breast, prostate, and colorectal cancer when used in conjunction with other clinical monitoring methods.

Since 2021, MSB has offered in the US a menu of non-invasive Laboratory Developed Tests (LDTs) provided through its CLIA/CAP accredited US-based Lab. The services include CMC enumeration, CTC enumeration and PDL-1/HER2 biomarker and offer a minimally invasive approach to follow cancer patient’s therapeutic journey.

In 2022, the company launched the CELLSEARCH Circulating Multiple Myeloma Cell (CMMC) Enumeration LDT, the first-of-its-kind, which directly measures levels of plasma cells in the blood of patients. This test provides new, complementary information to that of the bone marrow biopsy and other standard-of-care measures. Due to its minimally invasive nature, it can be performed serially to assess plasma cell burden without requiring repeated bone marrow biopsies.

Menarini's vision and uniqueness in oncology is to bring together innovative therapeutic solutions and advanced liquid biopsy-based diagnostics for faster, more effective and precise patient management.

It is an exciting time in the company’s development and an excellent opportunity for individuals joining us to contribute to building and shaping Menarini Stemline’s Oncology business.