Clinical Trial Associate - New York - Menarini Group

Description

Overview

Reporting to the Clinical Program/Trial Lead, the Clinical Trial Associate will provide clinical operational support to Clinical Trial Teams throughout the lifecycle of clinical trials. Responsibilities include assisting with the start-up, execution, and close-out phases. Success in this position relies on attention to detail, strategic planning, and meticulous follow-through.

Responsibilities

Acts as a central point of contact for the clinical trial team for designated project communications, correspondence, and associated documentation.

• Ownership and maintenance of trial SharePoint site.
• Ownership of electronic Trial Master File (eTMF) and maintenance of eTMF set up, organize, and maintain clinical study documentation (e.g. Trial Master File documents, email correspondence, training materials, etc.) including preparation for internal/external audits, periodic and final quality review and archival.
• Coordinate internal and external meeting agendas and minutes, as applicable. Responsible for preparing and distributing Clinical Trial Team (CTT) meeting agenda and capturing CTT meeting minutes.
• Assists the clinical trial team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the standard operating procedures.
• Assists with the maintenance of trial‑specific tracking reports (e.g. patient enrollment, regulatory documents, site visits, Adverse Event (AE/SAE), Protocol deviations).
• Supports the clinical trial team(s) in updating reports and management plans.
• Assists in the resolution of issues, questions, and process requests for additional study supplies.
• May participate and support responses to Quality Assurance and/or regulatory authority inspection audits and always maintain inspection readiness.
• Maintains trial specific training records, including preparation of the trial team list. Collaborates with Quality Assurance to ensure all appropriate team members are trained on trial specific plans and documents.
• Coordinates with trial vendors throughout the clinical trial lifecycle and maintains vendor list.
• Participates in company improvement initiatives.
• Assists in coordinating Investigator and third‑party payments.
• Act as a backup for other Clinical Trial Associates (CTAs) as needed.
• Can serve as a Clinical Operations Representative.
• Provides updates on clinical trial status on
• Supports preparation of Clinical Study Report and appendices as needed.

Qualifications

• Minimum 2 years in a clinical research environment.
• Experience in oncology is required.
• B.A./B.S. in life sciences or equivalent experience.
• Knowledge of clinical trial regulations, guidelines, and best practices, including ICH‑GCP and FDA requirements.
• Experience utilizing various eTMF platforms.
• Possess strong interpersonal, organizational, written and oral communication skills, and must be detail‑oriented.
• Work independently to prioritize tasks and manage multiple projects while operating under tight deadlines.
• Capable of developing complex reports and meticulously tracking administrative documents, including correspondence.
• Handle sensitive and confidential information with the utmost discretion.
• Collaborate across different organizations and work as part of a team to support departmental initiatives
• Proficient in Microsoft Suite/Office, Adobe Acrobat, and Smartsheet.

Please note: this position is classified as a corporate office position. In accordance with the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of whether these employees work in New York or remotely.

Base Salary Range of $115,000-$155,000. Menarini Stemline offers generous compensation and benefits packages, including Short-Term Incentive Programs, Fidelity 401(k) (with company match), Anthem Premier PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre‑tax FSA/HSA programs.

Menarini Stemline is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

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.