Job Description

• Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan. Oversees project-related education of investigators, study site personnel, and internal study staff.
• Provide medical oversight and safety monitoring for ongoing clinical trials including participation in SAE reporting. Review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.
• Establish and approve scientific methods for the design and implementation of applicable clinical protocols, data collection systems, and final reports.
• Responsible for scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, publications, and other program related documents.
• Provides in-house clinical expertise with internal stakeholders. May participate in business development activities as required by program needs.
• Acts as a clinical leader to actively interact with key opinion leaders related to the molecule and disease area.
• Participate in appropriate regulatory discussion and activities (i.e. the filing of IND and NDA). Responsible for understanding the regulatory requirements related to the clinical studies and complying with those requirements.

Ensures adherence to the highest level of Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting clinical study

Qualifications

• Medical Doctor (M.D.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
• At least 2 years of clinical trial experience in the pharmaceutical industry. Preferred 3+ years direct experience in oncology development in MNC (multinational company).
• Strong analytical and communication skills. Ability to interact externally and internally to support a global scientific and business strategy.
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.
• Must possess excellent oral and written English communication skills. Mandarin is highly preferred.

This role requires the incumbent to travel up to 30% of the time.

HR@medilinkthera.com

KEY DUTIES & RESPONSIBILITIES:

1. The Clinical Trial Manager will be responsible for leading the clinical study planning as well as development and management of study timelines, budget, resources, risk, and quality plans.
2. This role is responsible for collaborative and effective management of cross-functional study team activities, as well as communication with and management of multiple external vendors and stakeholders (e.g., CROs, central labs, IRBs/ECs, and other external partners)
3. S/he proactively identifies, manages, and communicates risks to key stakeholders and is also in communication and closely integrated with clinical trial sites, promoting relationship development with team members, stakeholders, Investigators, and site staff.
4. Coordinate cross-functional activities, leads the activities of the Clinical Trial Working Group, a cross-company and cross functional team, as it relates to study-level strategy, timelines, goals, and quality.
5. Acts as ad hoc member of the Clinical Development Sub-Team to collaborate in the program level development of clinical strategies, goal setting, and establishment of timelines.
6. Evaluates, selects, and ensures appropriate oversight of Contract Research Organizations (CROs) and other external vendors.
7. Builds solid relationships with key counterparts at CRO(s) and other external vendors.
8. Communicates with clinical trial sites as appropriate to ensure optimal Sponsor-Site relationships.
9. Communicates trial status within and outside the study team to ensure cross-functional alignment of expectations, priorities, and deliverables.
10. Provides input to the development of study-level budget(s) and demonstrates accountability for the management of assigned clinical study budget(s)
11. Tracking vendor performance against scopes of work, contracts, and invoices to ensure consistency between work performed and contractual agreement(s)
12. Facilitating review of study-level scopes of work, invoices, change request forms, and change orders to ensure consistency with study progress and/or evolving study needs.
13. Anticipates, recognizes, and manages issues, exhibits the ability to recognize the need to seek assistance from or inform Senior Management of specific risks/issues; understands when decision making can and needs to occur at the study team level versus when there is a need for escalation to the program level or to Senior Management
14. Analyzes clinical study and investigative site risks and implements corrective actions, where required.
15. Drives quality-by-design efforts to proactively identify and manage risks to trial quality and ensure MediLink is always inspection ready. Study Management and Oversight
16. Drives site start-up, subject enrollment, clinical monitoring activities, clinical site compliance and data metrics from CROs, central labs, and other external vendors
17. Leads development and execution of operational activities outlined in various study plans, SOPs, study procedures, etc.
18. Coordinates the development and distribution of critical study documents, including ICFs, operational documents, study reference documents, study newsletters, site materials, and other study related documents; reinforces the development of clinical study protocols, clinical study reports and other documents as needed.
19. Partners with Global Supply Chain (Technical Operations) team to provide oversight of the applicable study drug(s), including supply projections, distribution, labeling and destruction.
20. Tracks clinical study metrics and reports to management on study(ies) run by MediLink partners, as applicable.
21. Plans, facilitates, and monitors training at investigator meeting(s), internal and vendor kick-off meeting(s), and various CRO (or other vendor) meeting(s)
22. Performs quality assurance checks (e.g., reviewing protocols for operational effectiveness, monitoring trip reports for potential gaps in site/CRA training, conducting co-monitoring visits at clinical sites, reviewing data listings at interim analysis milestones)
23. Coordinates Independent Data Monitoring Committees (IDMCs), when applicable, including collecting confidentiality agreements, contracts, and conflict of interest forms from IDMC members, reviewing IDMC Charter, planning and scheduling meeting(s)
24. Supports and collaborates with GCP QA during site selection and site/study audit activities.
25. Leads Clinical Operations preparation of inspection readiness activities for FDA and other applicable regulatory body audits and/or meetings.
26. Provides guidance and shared learning within and across teams.
27. Mentors more junior Clinical Operations staff member(s) Participates in internal and external training programs to ensure skills are learned and maintained.
28. Champions operational best practices and seek opportunities for innovation and efficiencies within the Clinical Operations group.
29. Participates in internal MediLink SOP, WI, and/or template development and review.

Performs administrative functions and additional duties as assigned and appropriate

 

QUALIFICATIONS& REQUIREMENTS:

1. Bachelor’s degree with a life science or healthcare focus or nursing degree required.
2. Highly motivated and proactive self-starter, able to organize and perform complex tasks with minimal supervision.
3. Proven ability to effectively manage and provide oversight of CROs and multiple vendors for complex global protocols.
4. Ability to organize and manage multiple priorities required.
5. Strong team participation and leadership skills, including excellent oral and written communication skills required.
6. Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigator and site staff) using collaborative influence and negotiation skills.
7. Proficiency in Microsoft Word, Excel, and PowerPoint
8. Ability to multitask with significant attention to detail.
9. Ability and willingness to travel up to 20% of the time.

HR@medilinkthera.com