Clinical Development Medical Monitor

Your mission
As Clinical Development Medical Monitor, you will provide medical oversight across Ferrer's clinical studies, helping to ensure participant safety, data quality, and medically sound decision-making throughout the conduct of clinical trials.

Your essential role will be to provide medical expertise on all medically relevant matters, including medical consultation, medical data review, and review of essential study documents. You will also support the early identification of safety concerns across the clinical studies managed and overseen by Ferrer'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, you will help ensure that medical monitoring activities are conducted in line with protocol, regulatory requirements, and ethical standards. In addition, you will contribute to fostering strong medical and scientific relationships with the broader scientific community.

• 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.

• Make a positive impact in society
• Participate in volunteering activities
• Grow in a culture of trust, responsibility, and constructive feedback
• Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking
• Make a real difference to the team and to yourself
• Take advantage of opportunities for development & learning
• Discover a range of benefits to support your physical, emotional and financial wellbeing
• Customize your remuneration and benefit

You will rock at this company if you are a person with empathy, humility, curiosity and optimism.

You will rock at this role if you match with:

• 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 teams.

If this great challenge matches your profile, then we are waiting for you!