Medical Director, Early Phase
About the role
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At ICON, it's our people that set us apart.
As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them?
At ICON, we have an incredible opportunity for a Medical Director, Early Phase to join the team.
The Role: The Medical Director, Early Phase will have responsibility for the safety, well-being and rights of trial subjects.
- To have responsibility for the proper conduct of clinical trials.
- To lead a team of appropriately qualified physicians, nurses, technical and administrative staff members that participates in the studies design, protocol preparation, reports, and recruitment of volunteers, clinical trial procedures and publication of completed studies.
- To ensure that studies are being conducted in compliance with the protocol, Clinical Trials and Good Clinical Practice set out in FDA, ICH and other relevant regulatory and ethical guidelines.
- To be the lead individual for clinical and research governance within the Clinical Unit, setting and maintaining standards for training and assessment, specifically including the management of medical emergencies and resuscitation by the Clinical Unit staff, and ensuring that relevant clinical competence in the absence of the Sr. Medical Director is provided.
- To act as Principal Investigator or sub-Investigator for studies, playing an active role in the clinical trials, not just as a figurehead.
- To provide medical education for staff in the Clinical Unit when appropriate.
- To provide support ort for the Business Development team when appropriate.
What you will be doing:
- Recognize, exemplify and adhere to ICON's values, which center around our commitment to People, Clients and Performance.
- As a member of staff, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Travel (approximately 10%) domestic and/or international.
- Take an active part in the whole process of the clinical trials. Conduct qualification assessments, physicals, laboratory review, ECG review.
- Discuss new trials with other staff, sponsors and any other involved parties
- Assess the feasibility of conducting new trials under the auspices of available resources, equipment and expertise
- Review synopses, protocols and informed consent documents.
- Attend and present protocols, safety reports and other documents.
- Help with the medical issues involved in the screening and care of healthy volunteers and patients monitoring adverse events and safety issues on a regular basis and ensuring that adequate medical care is provided to a subject with an adverse event.
- Take an active part in initiation meetings.
- Sign the relevant CRF pages at the end of the study.
- Contribute to writing an end of study reports when necessary.
- Work within the context of the Unit's Standard Operating Procedures.
- Maintain confidentiality with regard to volunteers and clients in accordance with confidentiality agreements and the Contract of Employment.
- Keep knowledge and skills up-to-date through regular educational activities, which maintain and further develop competence and performance.
- Provide ongoing medical education to all personnel in the Clinical Unit in liaison with training facilitators and, if necessary, initiating training programs for the staff of the Clinical Unit.
- Attend any relevant meeting which is important to ICON Early Phase Services business objectives/goals.
- Represent ICON Early Phase Services in medical and scientific meetings, seminars, workshops and congresses, giving lectures or presenting papers and supporting marketing and sales activities.
- Assist in leading the Clinical Unit consisting of at team of nurses, technical and administrative staff, supported by the Clinical Management Team: Clinical Nurse Manager, Clinical Operations Manager, Clinical Quality & Training Manager and the Assistant to the Clinical Management Team.
- Maintain excellent professional standards in all aspects of duties, adhering to Unit dress codes and professional codes of conduct, and ensure the same is true for all Clinical Unit staff.
- Ensure that arrangements are in place to provide continuous medical and nursing coverage at all times
- Perform other duties as needed
Why join us?
Other than working with an outstanding
team of ambitious people, we also offer a very competitive benefits package.
This varies from country to country so a dedicated recruiter will discuss this
with you at interview stage.
We care about our people, as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term
career.
Ongoing development is vital to us, and as a Medical Director, Early Phase, you will have the opportunity to progress your career, with the potential to move into other related areas to improve your skillset. Our benefits package is competitive, our scope is international and we sincerely care about our people and their success.
ICON is an equal opportunity employer
and committed to providing a workplace free of any discrimination or
harassment.
EOE race/color/religion/sex/sexual orientation/gender
identity/disability/vet/national origin
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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