Project Manager CRA English Fluent
1 day ago
Seville
Hays is collaborating with privately owned pharmaceutical company headquartered in Barcelona, with vertical integration covering the entire value chain from R&D 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. We are looking for a Project Manager CRA 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. To 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. As 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. What would your duties be? • 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 the early identification of safety concerns across clinical studies., • Review and classify protocol deviations and assess exclusionary or alert laboratory values, as well as 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 enrolment activities when appropriate. Which are the requirements for this position? • 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. This is consistent with the operational and medical-review focus described in the intake., • 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 both 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 crossfunctional team. What we offer? • Stable Project., • Flexible schedule., • Participate in international projects., • Flexible work., • Location: Barcelona but can be remote., • If 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).
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