[Hiring] Medical Manager @Parexel

Role Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities:

• Project Execution: Medical Monitoring Delivery & PV Support
  • Deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor.
  • Participate actively in study planning with feasibility leaders, solution consultants, and other medical representatives.
  • Participate in team project and investigator meetings.
  • Provide training of study teams on TA indication and protocol.
  • Communicate with relevant sponsor counterparts on challenges and accomplishments related to assigned project/study.
  • Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans, Medical Data Review Plan design and implementation, integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc.
  • Deliver medical monitoring activities according to MMP during the study conduct.
  • Answer to site/study team questions relating to the study conduct or protocol.
  • Review and sign off all data listings/tables, protocol deviations, datasets, for medical accuracy/consistency.
  • Deliver medical support to the project in close coordination with the Medical Monitor/Global Lead Physician.
  • Timely identifying risks and challenges.
  • Pro-actively proposing and/or delivering relevant actions contributing to the success of the study/project and risk mitigation.
  • Creating a sense of urgency on any matters pertaining to safety of study participants and scientific integrity of the study.
  • Attend and support any audits or inspections pertaining to assigned studies.
  • Participate in periodic rotas including night and weekend shifts for emergency medical contact and emergency unblinding phone requests.
  • Provide medical input into PV workflows and projects and participate in safety processing for studies.
  • Function as pharmacovigilance representative/safety scientist.
  • Support regulatory safety reporting activities.
  • Work as Subject Matter Expert (SME).
  • Provide input for process improvements.
  • Work closely with Project Lead/Functional Lead for process coordination and to ensure meeting all Key Performance Indicators (KPIs).
• Client Relationship Building & Engagement
  • Actively listen to, solicit, and address client feedback and suggestions regarding medical study-related activities.
  • Follow up satisfaction metrics pertaining to medical activities in assigned studies and propose/excute remediation plan.
• Business Development
  • Support Business Development while balancing time devoted to this activity with billable tasks.
  • Provide medical expertise/leadership in Proposal Development Teams (PDTs).
  • Attend/support bid defense meetings as requested.
  • Provide support for marketing activities as requested.
  • Share sponsor insights and experiences with peer and proposal teams.
• Medical Expertise
  • Provide medical expertise to clients across multiple channels and interactions.
  • Input into protocol development.
  • Medical review of various documents.
  • Provide medical expertise and training to other Parexel colleagues.
  • Mentoring of junior Medical Advisors/serving as team Line Manager.
  • Write clear, concise medical documents.
  • Participate in activities to raise, coordinate and promote Parexel medical expertise.
  • Attend preparation and Bid pursuit meetings as appropriate.

Qualifications

• Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts.
• Client-focused approach to work.
• Excellent time management skills.
• Excellent verbal and written medical communication skills.
• Excellent standard of written and spoken English.
• A flexible attitude with respect to work assignments and new learning.
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
• Willingness to work in a matrix environment and to value the importance of teamwork.

Requirements

• Experience in clinical medicine (general or specialist qualifications) with a specialty in a therapeutic area.
• Clinical practice experience.
• Expertise in clinical aspects of drug development, including medical data review and/or Medical Monitoring and study design/execution.
• Well versed knowledge of drug development processes including drug safety.
• Relevant experience in Pharmaceutical Medicine.
• Wide knowledge in medical aspects of GCP, ICH, FDA, EMEA and other relevant guidelines.
• At least 3 years of medical monitoring or medical data review experience.

Education

• Medically qualified in an acknowledged medical school with completion of at least a basic training in clinical medicine (residency, internship).