Project Manager Cra English Fluent; Marzán

Puesto: Project Manager Cra English Fluent (Marzán)
Overview  Hays is collaborating with a privately owned pharmaceutical company headquartered in Barcelona, founded in 1959. The company operates in more than 110 countries through 19 international subsidiaries and covers the entire pharmaceutical value chain from R&D to distribution. It serves the pharmaceutical, healthcare, fine chemicals, and nutrition sectors with a focus on improving people’s health and quality of life.

Key Responsibilities   Provide medical consultation on study–related matters, including participant eligibility, protocol–related questions, efficacy and safety procedures, concomitant medication, adverse events, and SAE reporting.
Review SAE narratives and support early identification of safety concerns across clinical studies.
Review and classify protocol deviations and assess exclusionary or alert laboratory values, and other relevant testing data.
Support the medical review of participant data listings, patient profiles, and medically coded terms to ensure consistency and medical appropriateness.
Provide guidance on investigational product administration issues when needed.
Lead medical discussions and teleconferences with internal study teams and external clinical service providers, including CROs.
Deliver therapeutic area and/or protocol training to relevant study team members.
Contribute to IRB/Ethics Committee and regulatory authority submissions when required.
Review and, when needed, co‑author key study documents such as protocols, Medical Monitoring Plans, Safety Management Plans, Informed Consent Forms, and Clinical Study Reports.
Support patient enrollment activities when appropriate.
Requirements   Medical Degree with Registration Certificate.
At least 3 years of experience in Clinical Research.
GCP training.

Advanced level of English.
Experience reviewing clinical and safety data within clinical trials.

Strong medical judgment and the ability to interpret clinical data in a development context.

Good interpersonal skills and the ability to build effective relationships with internal and external stakeholders.
Strong communication and presentation skills, with the ability to communicate clearly and concisely in writing.
Strategic thinking, attention to detail, and the ability to work effectively in cross‑functional teams.
Benefits   Stable Project role.
Versatile schedule with flexible work options.
Participation in international projects.

Location:

Barcelona, with remote work available.

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