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 (i.e., tasks and time per task contracted) and according to the assigned role (generally Regional Lead Physician or Medical Monitor support role).
- 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 (Note that this does not include any direct medical advice on patient care or management)
- 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
- (MMP), Medical Data Review Plan (MDRP) design and implementation, integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc. in conjunction with clients / sponsors or in conjunction with other Parexel departments.
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 in accordance with study plans (Medical Monitoring Plan, Medical Data Review Plan, Data Surveillance Plan etc.)
Deliver medical support to the project in close coordination with the Medical Monitor / Global Lead Physician, and according to the role assigned by:
- 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 even if not directly involved in the audited activities.
- Participate in periodic rotas including night and weekend shifts e.g. for emergency medical contact and emergency unblinding phone requests for Parexel studies, as applicable and/or appropriate for the MD.
- Provide medical input into PV workflows and projects and participate in safety processing for studies including medical review of serious adverse events.
- 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) for the process.
Client Relationship Building & Engagement
- Actively listen to, solicit, and address client feedback and suggestions regarding medical study-related activities to enhance client satisfaction.
- Follow up satisfaction metrics pertaining to medical activities in assigned studies and propose / execute remediation plan in coordination with line manager and Project Leader in case of client dissatisfaction.
Business Development
- Support Business Development, as agreed with line manager, while adequately balancing time devoted to this activity with billable tasks.
- Provide medical expertise / leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings with the help/support of more senior MD.
- Attend/support bid defense meetings as requested.
- Provide support for marketing activities as requested.
- Share sponsor insights and experiences (strategy, history, culture, priorities, etc.) with peer and proposal teams with peer and proposal teams.
Medical Expertise if appropriate level of expertise on a given indication
- Provide medical expertise, as agreed by line manager, to client across multiple channels and interactions such as:
- Input into protocol development.
- Medical review of various documents, which might be audited by clients and regulatory agencies.
- Provide medical expertise and training to other Parexel colleagues.
- Mentoring of junior Medical Advisors/ serving as team Line Manager as applicable
- As appropriate, write clear, concise medical documents.
- Participate in activities to raise, coordinate and promote Parexel medical expertise both internally and externally including but not limited to internal therapeutic area meetings, training modules development, white papers, slide sets, publications etc.
- Attend preparation and Bid pursuit meetings as appropriate
Skills:
- 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.
Knowledge and Experience:
- Experience in clinical medicine (general or specialist qualifications) with a specialty in a “therapeutic area,” which is expected to be kept up to date.
- 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)