Additional Information
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:
Delivery & PV Support:
Participate actively in study planning with feasibility leaders, solution consultants
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), 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 leadership to the project in close coordination with the Project Leader and according to the role assigned (GLP or RLP) 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
Participating in periodic rotes 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 risk assessment of clinical trials for local sponsorship as needed with the support of the designated Senior Medical Director or Section Head
Provide medical input into PV workflows and projects and participate in safety processing for studies including medical review of serious adverse events.
Supporting regulatory safety reporting activities
Client Relationship Building & Engagement:
Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities in order 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 Section Head or line manager, while adequately balancing time with billable tasks
In line with business development objectives, meet and attend phone conferences with clients to communicate and detail Parexel medical expertise and experience in a therapeutic area or in an indication.
Provide medical expertise / leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings
Attend preparation meeting and Bid pursuit meetings as required
Provide support for marketing activities as requested.
Share sponsor insights and experiences (strategy, history, culture, priorities etc.) with peer and proposal teams
Medical Expertise:
Provide medical expertise to client as contracted across multiple channels and interactions such as:
Consultancy on protocol development or drug development program
Medical review of various documents, which might be audited by clients and regulatory agencies
Provide medical expertise and training to other Parexel colleagues
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.
Parexel · China-shanghai Shinmay