Parexel

Key Responsibilities

• • Independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor and assigned role.
• • Participate actively in study planning with feasibility leaders and solution consultants.
• • Participate in team project and investigator meetings.
• • Provide training of study teams on therapeutic area 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, integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc.
• • Deliver medical monitoring activities according to Medical Monitoring Plan during study conduct.
• • Answer site/study team questions relating to study conduct or protocol.
• • Review and sign off all data listings, protocol deviations, datasets for medical accuracy/consistency in accordance with study plans.
• • Deliver medical leadership to the project in close coordination with the Project Leader according to assigned role.
• • Timely identify risks and challenges and propose or deliver relevant actions contributing to study/project success and risk mitigation.
• • Create a sense of urgency on matters pertaining to safety of study participants and scientific integrity of the study.
• • Attend and support 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 as applicable.
• • Provide risk assessment of clinical trials for local sponsorship as needed.
• • Provide medical input into pharmacovigilance workflows and projects and participate in safety processing including medical review of serious adverse events.
• • Support regulatory safety reporting activities.
• • Utilize metrics and key performance indicators to ensure high quality, cost effective delivery of medical services.
• • Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities.
• • Follow up satisfaction metrics pertaining to medical activities and propose/execute remediation plans if needed.
• • Integrate and prioritize client interest and needs to build trust and demonstrate credibility.
• • Be a point of escalation for issues and arrange resolution through interaction and negotiation with appropriate departments and senior leadership.
• • Drive continuous improvements in meeting client expectations.
• • Autonomously support Business Development while balancing time with billable tasks.
• • Meet and attend phone conferences with clients to communicate Parexel medical expertise and experience.
• • Provide medical expertise/leadership in Proposal Development Teams for client bid pursuit meetings.
• • Attend preparation and bid pursuit meetings as required.
• • Provide support for marketing activities as requested.
• • Share sponsor insights and experiences with peer and proposal teams.
• • Develop a vision and make recommendations within own area of expertise to grow Parexel activities.
• • Coach and mentor junior team members on effective collaboration with clients.
• • Work with Section Head to develop expertise in therapeutic area including training internal colleagues.
• • Provide senior/advanced medical expertise across multiple channels and interactions.
• • Consult on protocol development or drug development programs.
• • Medically review various documents which might be audited by clients and regulatory agencies.
• • Write clear, concise medical documents including complex and strategic matters.
• • Initiate and participate in activities to raise, coordinate and promote Parexel medical expertise internally and externally.
• • Support patient centricity, diversity and inclusion in all projects.
• • Participate in internal initiatives to improve Parexel and GMS operational model.
• • Contribute to development of departmental capabilities including procedures and technology.
• • Work with Section Heads to ensure development and performance of self and team.
• • Create a culture of continuous improvement and lead team through change to deliver desired outcomes.
• • Support timely assignment of MD to proposals, projects and studies.
• • Manage team members according to Parexel tools, guidelines and procedures.
• • Guide, energize, motivate and coach team members to perform at top of abilities in line with Parexel values and career goals.
• • Support talent development of team and create environment and opportunities for team members to thrive.
• • Mentor/manage team through clear definition of accountabilities and expectations, assigning tasks/projects based on competencies and skills and helping staff prioritize workload.
• • Maintain adequate billability rate and efficient ratio between workload and personal life according to local guidelines.
• • Provide efficient support to business development activities including proposals, bid pursuit meetings, capability meetings.