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Senior Clinical Project Manager

Hybrid in Barcelona·Full-time·Added today (last checked 30 Oct)

ONA Therapeutics

1 open role

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Our summary

Work mode: Hybrid, Barcelona
Contract: Permanent, full-time hours
Spanish: Fluent
English: Required
Experience: 8+ years
Education: Master's degree

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Skills

Requirements

What we're looking for

Master's or PhD degree in oncology setting
>8 years of experience in clinical operations, managing CROs and vendors
Strong clinical operations background.
Extensive knowledge of GCP and clinical trial processes.
Experience in working on the sponsor, ideally for a small company.
Ability to work in a high-pressure, deadline-driven environment.
Excellent communication and reporting capabilities.
Strong project management skills with methodical, organized, and meticulous practices.
Strong cooperative team player, ability to be flexible
Fluency in English and Spanish.

Nice to have

Master's degree in clinical trial management highly valued

Pay & benefits

What you'll get

A competitive salary package matching with the qualifications and experience of the candidate.

The role

Ona Therapeutics is a clinical stage biotech company located in Barcelona (Parc Científic de Barcelona, PCB), focused on developing first-in-class antibody drug conjugates (ADCs) for advanced cancer treatment. By partnering with leading academics and clinicians, we identify novel therapeutic targets from the unique biology of treatment refractory advanced cancer patients, to provide effective new treatments for patients with no remaining alternatives.

We are seeking an experienced Senior Clinical Project Manager with a strong background in early-phase oncology and biological compounds, such as monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs). The ideal candidate will have significant experience in a biotech setting, demonstrating the ability to operate within small and agile teams.

What you'll do

Lead clinical CRO and vendor selection processes
Responsible for initiation, execution, oversight and closure of ONA clinical trials within budget and timelines
Manage CROs and other vendors to ensure adherence to trial protocols, including PK/PD, data management, statistics, medical writing, regulatory affairs, clinical supplies, pharmacovigilance.
Primary contact for CROs, other vendors and clinical sites for operational execution of the trials and leading the contract negotiations with these external parties
Oversee clinical trial site selection and initiation
Participate in the development of clinical trial protocols, case report forms, and informed consent documents.
Monitor and optimize clinical supply availabilities and patient recruitment
Monitor clinical trial budget and ensure financial compliance.
Ensure compliance with ICH, SOPs, local regulations, and applicable guidelines.
Support CRO in conducting site monitoring visits to ensure data quality and integrity.
Participate in risk management and contingency planning.
Support the CMO in preparing scientific materials related to the company's product portfolio.
Collaborate in the development and documentation of Standard Operating Procedures (SOPs)

About ONA Therapeutics

ONA Therapeutics is a clinical-stage biotechnology company headquartered in Barcelona, Spain, dedicated to developing innovative antibody-drug conjugates (ADCs) for hard-to-treat cancers. The company leverages deep expertise in cancer biology and antibody engineering to create precision therapies targeting refractory tumors, with a pipeline including ONA-255ADC for breast cancer and solid tumors. As a spin-off from IRB Barcelona, it maintains strong ties to academic research and operates with a multidisciplinary team of scientists and operational staff.

Industry: Biotechnology
Founded: 2019
Employees: 11–50
Headquarters: Barcelona, Spain
In Spain: Barcelona, Madrid

Good to know if you are moving

ONA Therapeutics is headquartered in Barcelona, Spain, with an additional office in Madrid, offering opportunities in two major Spanish cities.
The company is a spin-off from IRB Barcelona, providing a research-driven environment with strong academic connections.
The team is international, with scientists and staff from various countries, and the working language is likely English.
The company is in a growth phase, with a focus on drug development, which may offer career progression in a dynamic biotech setting.
Spain offers a favorable climate, vibrant culture, and a lower cost of living compared to other European hubs, making it attractive for international professionals.

In their own words

About the company & team

A work environment, culture and passionate team focusing on unravel novel biology to design biopharmaceuticals attacking advanced cancer organization.
A unique opportunity to work in an innovative and dynamic environment.

All open roles at ONA Therapeutics