Takeda Pharmaceutical Looking for Lead Clinical Trial Associate at Boston, MA Full Time

For assigned complex, accelerated, and/or business critical studies, provide support to focus on study start-up and site initiation activities, including but not limited to:

• May support more complex programs and studies to define and execute best clinical trial support strategies.

• Review and/or approval of study documentation, including essential document packets, study plans, informed consent forms, etc.

• Supporting oversight of risk-based monitoring.

• Attendance of key team meetings as required; may make presentations (e.g. data, resourcing, initiatives, etc.).

• May make presentations to senior leadership of therapeutic areas and/or R&D functional areas.

• Supporting regulatory inspection readiness (e.g. preparation of materials and/or participation and/or oversee deliverables and milestones and/or lead CTA team during regulatory inspections and/or develop strategies for regulatory inspections.)

• Supporting additional ad-hoc activities as needed, as agreed with CTA Manager.

For all assigned studies, provide support including:

• Collaboration with internal departments (Legal, Insurance, R&D functions, etc.), CROs, and external vendors.

• Escalation of clinical trial insurance issues.

• Supporting Health Care Provider Engagement for facilitating contracts and meetings.

• Supporting vendor contract administration as required.

Provide support for departmental tasks, including but not limited to:

• Maintaining knowledge and acts as team super-user or subject matter expert for related systems and processes; provide presentations, training, and support to CTA team as needed; provide updates to applicable CTA resources as needed.

• May make presentations to Clinical Operations.

• Participating in and/or leading and/or initiating functional initiatives and/or working groups.

• Assisting with special projects and/or tasks as required.

• Acting as mentor to junior CTA team members.

• Supporting new CTA team member onboarding.

Perform developmental tasks as appropriate with oversight of CTA Manager, including:

Technical/Functional (Line) Expertise

• Provide expertise in complex start-up activities and operating model to study teams.

• Understanding and application of GCP, ICH, and applicable regulatory standards governing clinical research.

• Comfortable with technology and able to learn new systems quickly.

• Strong knowledge of MS Word, Excel, PowerPoint, and Outlook.

• Managing deliverables; demonstrating the ability to lead others to drive deliverables forward.

• Lead and/or supervise complex projects.

• Navigation of changing priorities and communication about changes.

Decision-making and Autonomy

• Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands.

• Ability to work with timelines and complete tasks according to deadline.

• Problem solving study-related issues; demonstrating resourcefulness, independence, and leadership; escalation of issues as needed.

• Must be able to professionally interact and communicate with internal departments (Legal, Insurance, R&D functions, etc.), CROs, external vendors, and senior leadership of therapeutic areas and R&D functions).

• Ability to effectively collaborate with both internal and external study team.

• Ability to work in a matrix environment.

• Coordination with external vendors as needed.

• Knowledge sharing with study teams as needed.

• Working with process owner for optimization of the process.

• Knowledge sharing with the CTA team as needed.

• Requires strong attention to detail in composing and/or proofreading and/or approving study materials, establishing priorities, scheduling, and meeting deadlines.

• Ability to take ownership and manage tasks, as well as communicate effectively.

• Assigned clinical studies may be high complexity and/or high risk.

• More than one study and/or more than one program may be assigned.

• Interactions with study teams and other colleagues are both local and remote (in varying locations and timezones).

• 4-5 years’ experience in pharmaceutical industry, clinical research organization, or related role.

• Experience in Phase 2 and 3 studies and global/international studies is advantageous.

• Experience working across multiple therapeutic areas (including oncology) is advantageous.

• Knowledge in global regulatory and compliance requirements for clinical research.

• Demonstrated excellence in task management and cross-functional collaboration.

• Excellent leadership skills.

• Excellent communication skills.

• Excellent teamwork, organizational, interpersonal, and problem-solving skills.

• Fluent business English (oral and written).