pHays is collaborating with privately owned pharmaceutical company headquartered in Barcelona, with vertical integration covering the entire value chain from RD to distribution founded in 1959. The company operates in more than 110 countries through 19 international subsidiaries. Its activities span the pharmaceutical, healthcare, fine chemicals, and nutrition sectors—key areas for contributing to improvements in people’s health and quality of life. /ppbr/ppWe are looking for astrong Project Manager CRA /strong to join their team and provide medical oversight across company clinical studies, helping to ensure participant safety, data quality, and medically sound decision-making throughout the conduct of clinical trials. /ppbr/ppTo provide medical expertise on all medically relevant matters, including medical consultation, medical data review, and review of essential study documents. Also, give support the early identification of safety concerns across the clinical studies managed and overseen by company’s Clinical Development Department, ensuring a consistent and standardized approach to medical monitoring activities. /ppbr/ppAs a key medical partner to internal teams and external providers, especially CROs, help ensure that medical monitoring activities are conducted in line with protocol, regulatory requirements, and ethical standards. In addition, contribute to fostering strong medical and scientific relationships with the broader scientific community. /ppbr/ppstrongWhat would your duties be? /strong /pulliProvide medical consultation on study-related matters, including participant eligibility, protocol-related questions, efficacy and safety procedures, concomitant medication, adverse events, and SAE reporting. /liliReview SAE narratives and support the early identification of safety concerns across clinical studies. /liliReview and classify protocol deviations and assess exclusionary or alert laboratory values, as well as other relevant testing data. /liliSupport the medical review of participant data listings, patient profiles,



and medically coded terms to ensure consistency and medical appropriateness. /liliProvide guidance on investigational product administration issues when needed. /liliLead medical discussions and teleconferences with internal study teams and external clinical service providers, including CROs. /liliDeliver therapeutic area and/or protocol training to relevant study team members. /liliContribute to IRB/Ethics Committee and regulatory authority submissions when required. /liliReview and, when needed, co-author key study documents such as protocols, Medical Monitoring Plans, Safety Management Plans, Informed Consent Forms, and Clinical Study Reports. /liliSupport patient enrolment activities when appropriate. /li /ulpbr/ppstrongWhich are the requirements for this position? /strong /pullistrongMedical Degree with Registration Certificate. /strong /lilistrongAt least 3 years of experience in Clinical Research. /strong /lilistrongGCP training. /strong /lilistrongAdvanced level of English. /strong /lilistrongExperience reviewing clinical and safety data within clinical trials. This is consistent with the operational and medical-review focus described in the intake. /strong /lilistrongStrong medical judgment and the ability to interpret clinical data in a development context. /strong /liliGood interpersonal skills and the ability to build effective relationships with both internal and external stakeholders. /liliStrong communication and presentation skills, with the ability to communicate clearly and concisely in writing. /liliStrategic thinking, attention to detail, and the ability to work effectively in crossfunctional team. /li /ulpbr/ppstrongWhat we offer? /strong /pulliStable Project. /liliFlexible schedule. /liliParticipate in international projects. /liliFlexible work. /liliLocation: Barcelona but can be remote. /liliIf we finally continue with your candidature in the recruitment process, at the end of it, we will request 2 previous references (it is part of the HAYS policy that any person who joins into our clients can provide contacts for making references process). /li /ul

📌 Project Manager CRA English Fluent (Vitoria-Gasteiz)
🏢 Talent
📍 Vitoria-Gasteiz