Lead Clinical Trial Associate

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Lead Clinical Trial Associate

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Clinical Trial Associate/Lead Clinical Trial Associate remotely.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliverBetter Health and a Brighter Futureto people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

TAK-279 is a potential best-in-class, oral allosteric tyrosine kinase 2 (TYK2) inhibitor currently in development for the treatment of psoriasis and psoriatic arthritis. Takeda will evaluate TAK-279 in additional immune-mediated diseases including systemic lupus erythematosus (SLE) and Inflammatory Bowel Disease (IBD).

The remote-based Lead Clinical Trial Associate (CTA) will independently perform tasks related to supporting operational strategy, planning, and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.

• Provide support for critical day-to-day clinical study activities, in accordance with established protocols under the general supervision of the CTA Manager.

• Provide oversight of deliverables and milestones and/or lead CTA team during regulatory inspections and/or develop strategies for regulatory inspections.

• Collaborate with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.

• Provide leadership to the CTA team and study teams for more complex studies.

• Perform departmental tasks as needed, including acting as a subject matter expert or lead initiatives and/or processes; make presentations to Clinical Operations; act as mentor to junior CTA team members.

• Perform developmental tasks as appropriate with oversight of CTA Manager.

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:

• Career development and goal setting.

• Targeted skill development and/or growth of knowledge base.

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.

Leadership

• 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.

Interaction

• 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.

Innovation

• Knowledge sharing with study teams as needed.

• Working with process owner for optimization of the process.

• Knowledge sharing with the CTA team as needed.

Complexity

• 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).

Education

• Bachelor’s degree or equivalent international degree required.

Experience

• 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.

• Gastroenterology and Dermatology experience are strongly preferred

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

Skills

• 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).

TRAVEL REQUIREMENTS:

Requires availability for 5-10% domestic and/or international travel, including overnight and international travel on an as-needed basis.

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs

Location and Salary Information:

• Location(s): Remote
• Base Salary Range: $79,000.00 - $114,000.00 is based on candidate professional experience level. Employee may also be eligible for Short Term and/or Long Term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off
• The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

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