Parexel

Medical Director - CNS

Company
Parexel
Location
Romania
Salary
Competitive
Posted
07 Jan 2021
Closes
06 Feb 2021
Ref
64176BR
Discipline
Medical Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Job Description

Parexel's Clinical Neurosciences (CNS) Team is expanding!

Are you a Physician with a strong clinical research background in Neurology / CNS?

We are recruiting for a European based Medical Director, specialising in Neurology / CNS. This is an exciting opportunity to work on cutting edge CNS Projects.

You will be responsible for:
- Answering day to day medical and scientific questions, provide daily medical support to our staff or site (investigator/study coordinator)
- Review and sign off Data Management listings of safety data(including adverse events, laboratory data, vital signs data, medical history, physical examination, concomitant medication), establish the presence or absence of clinically meaningful trends and, if noted, follow up as appropriate with the project team, sponsor, investigator, and Regulatory Authorities
-Review and sign off technical documents written by Parexel with respect to medically relevant matters with particular attention to those relating to drug safety
- Review coding of adverse events and concomitant medications for accuracy and consistency
- Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents for clients/sponsors in conjunction with clients/sponsors or in conjunction with other PAREXEL departments
- Attend and present material (such as therapeutic area training) as requested, at internal and external meetings (e.g. investigator meetings)
- Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
- Maintain up-to-date knowledge of therapeutic area expertise by attending Professional Society Meetings
Provide support for marketing activities as requested
- Provide medical expertise to clients and internal staff
- Provide support to Business Development and attend Bid Defence meetings when requiredQualifications

Medical Leadership
Deliver medical leadership and support required for successful delivery of the projects according to contracted agreement with the sponsor, including, but not limited to the following activities:
•Participate in study planning w/ feasibility leaders, solution consultants, project team members, especially Project Leader as appropriate
•Provide training/support for training to study teams on TA indication and protocol

Job Qualifications:
•Provide risk assessment of clinical trials for local sponsorship as needed
•Provide medical input into PV workflows and projects and participate in safety processing for studies including medical review of serious adverse events, as needed
•Support regulatory safety reporting activities, as needed
•Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities in order to enhance client satisfaction and build the relationship
•Communicate w/ sponsor counterparts on challenges and accomplishments related to assigned project/study awards
•Timely identification of project risks and challenges, pro-actively proposing and/or delivering relevant actions contributing to the success of the study/project and risk mitigation
•Be a point of escalation for issues and arrange for resolution by effective interaction and negotiation with appropriate departments and senior leadership.

Requirements
Medical Doctor (M.D, MBBS, MBChB or equivalent)
PhD advantageous
Clinical specialisation in Neurology / CNS.
Experience in clinical trials is essential
Demonstrated competence as a Study Director / Medical Monitor / Research Physician / Principal Investigator / Sub-Investigator / Medical Advisor / Study Physician / Clinical Development Physician.
Prior experience working with the FDA or EMEA on responses to inquiries for study related information is not required but is preferredWhy Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.