What are the responsibilities and job description for the Lead Clinical Trial Associate position at Takeda Pharmaceuticals?
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**Job Description**
**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 deliver **_Better Health and a Brighter Future_** to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
**_OBJECTIVES_**
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 establishedprotocols under the general supervision of the CTA Manager.
Provideoversight of deliverables and milestones and/or lead CTA team duringregulatoryinspections and/or develop strategies for regulatoryinspections.
Collaborate with Clinical Operations Manager, study teams, and Clinical ResearchOrganizations (CROs) to support clinical study activities asdefined by the clinical trial operating model.
Provide leadership to the CTA team and study teams for more complex studies.
Performdepartmental tasks asneeded, includingactingas a subjectmatterexpert or lead initiatives and/or processes; make presentations to Clinical Operations; act asmentor to junior CTA team members.
Performdevelopmental tasks as appropriate with oversight of CTA Manager.
**_ACCOUNTABILITIES:_**
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 complexprograms and studies to define and execute best clinical trial support strategies.
Review and/or approval of study documentation, includingessentialdocumentpackets, study plans, informedconsentforms, etc.
Supportingoversight of risk-based monitoring.
Attendance of key team meetings asrequired; may make presentations (e.g. data, resourcing, initiatives, etc.).
May make presentations to senior leadership of therapeuticareas and/or R&D functionalareas.
Supportingregulatoryinspectionreadiness (e.g. preparation of materials and/or participationand/or oversee deliverables and milestones and/or lead CTA team duringregulatoryinspections and/or develop strategies for regulatoryinspections.)
Supportingadditional ad-hoc activities asneeded, asagreed 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.
**_DIMENSIONS AND ASPECTS:_**
Technical/Functional (Line) Expertise
Provide expertise in complexstart-up activities and operating model to study teams.
Understanding and application of GCP, ICH, and applicableregulatory 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 othersto drive deliverables forward.
Lead and/or supervisecomplex projects.
Navigation of changingpriorities and communicationaboutchanges.
Decision-making and Autonomy
Ability to work in a fast-pacedenvironment with demonstratedability to manage multiple competing tasks and demands.
Ability to work with timelines and complete tasks according to deadline.
Problem solving study-relatedissues; demonstratingresourcefulness, independence, and leadership; escalation of issuesasneeded.
Interaction
Must be able to professionallyinteract and communicate with internaldepartments (Legal, Insurance, R&D functions, etc.), CROs, externalvendors, and senior leadership of therapeuticareas and R&D functions).
Ability to effectively collaborate with bothinternal and external study team.
Ability to work in amatrixenvironment.
Coordination with externalvendorsasneeded.
Innovation
Knowledge sharing with study teams asneeded.
Working with processowner for optimization of the process.
Knowledge sharing with the CTA team asneeded.
Complexity
Requires strong attention to detail in composing and/or proofreading and/or approving study materials, establishingpriorities, scheduling, and meeting deadlines.
Ability to take ownership and manage tasks, aswellascommunicateeffectively.
Assigned clinical studies may be high complexity and/or high risk.
More than one study and/or more than one programmay be assigned.
Interactions with study teams and othercolleagues are bothlocal and remote (in varying locations and timezones).
**_EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_**
**Education**
**Bachelor's** **degree** **or** **equivalent** **international degree** **required** **.**
**Experience**
4-5years' experience in pharmaceuticalindustry,clinicalresearchorganization, or relatedrole.
Experience in Phase 2 and 3 studies and global/international studiesisadvantageous.
Experience working acrossmultipletherapeuticareas (includingoncology)isadvantageous.
**Skills**
Knowledge in global regulatory and compliance requirements for clinical research.
Demonstratedexcellence in task managementand cross-functionalcollaboration.
Excellent leadership skills.
Excellentcommunication skills.
Excellentteamwork, 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
If candidate is not eligible for any benefits or other comp., those can be excluded
**Empowering Our People to Shine**
Discover more at **takedajobs.com**
No Phone Calls or Recruiters Please.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
Massachusetts - Virtual
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
\#LI-Remote
**Job Description**
**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 deliver **_Better Health and a Brighter Future_** to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
**_OBJECTIVES_**
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 establishedprotocols under the general supervision of the CTA Manager.
Provideoversight of deliverables and milestones and/or lead CTA team duringregulatoryinspections and/or develop strategies for regulatoryinspections.
Collaborate with Clinical Operations Manager, study teams, and Clinical ResearchOrganizations (CROs) to support clinical study activities asdefined by the clinical trial operating model.
Provide leadership to the CTA team and study teams for more complex studies.
Performdepartmental tasks asneeded, includingactingas a subjectmatterexpert or lead initiatives and/or processes; make presentations to Clinical Operations; act asmentor to junior CTA team members.
Performdevelopmental tasks as appropriate with oversight of CTA Manager.
**_ACCOUNTABILITIES:_**
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 complexprograms and studies to define and execute best clinical trial support strategies.
Review and/or approval of study documentation, includingessentialdocumentpackets, study plans, informedconsentforms, etc.
Supportingoversight of risk-based monitoring.
Attendance of key team meetings asrequired; may make presentations (e.g. data, resourcing, initiatives, etc.).
May make presentations to senior leadership of therapeuticareas and/or R&D functionalareas.
Supportingregulatoryinspectionreadiness (e.g. preparation of materials and/or participationand/or oversee deliverables and milestones and/or lead CTA team duringregulatoryinspections and/or develop strategies for regulatoryinspections.)
Supportingadditional ad-hoc activities asneeded, asagreed 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.
**_DIMENSIONS AND ASPECTS:_**
Technical/Functional (Line) Expertise
Provide expertise in complexstart-up activities and operating model to study teams.
Understanding and application of GCP, ICH, and applicableregulatory 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 othersto drive deliverables forward.
Lead and/or supervisecomplex projects.
Navigation of changingpriorities and communicationaboutchanges.
Decision-making and Autonomy
Ability to work in a fast-pacedenvironment with demonstratedability to manage multiple competing tasks and demands.
Ability to work with timelines and complete tasks according to deadline.
Problem solving study-relatedissues; demonstratingresourcefulness, independence, and leadership; escalation of issuesasneeded.
Interaction
Must be able to professionallyinteract and communicate with internaldepartments (Legal, Insurance, R&D functions, etc.), CROs, externalvendors, and senior leadership of therapeuticareas and R&D functions).
Ability to effectively collaborate with bothinternal and external study team.
Ability to work in amatrixenvironment.
Coordination with externalvendorsasneeded.
Innovation
Knowledge sharing with study teams asneeded.
Working with processowner for optimization of the process.
Knowledge sharing with the CTA team asneeded.
Complexity
Requires strong attention to detail in composing and/or proofreading and/or approving study materials, establishingpriorities, scheduling, and meeting deadlines.
Ability to take ownership and manage tasks, aswellascommunicateeffectively.
Assigned clinical studies may be high complexity and/or high risk.
More than one study and/or more than one programmay be assigned.
Interactions with study teams and othercolleagues are bothlocal and remote (in varying locations and timezones).
**_EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_**
**Education**
**Bachelor's** **degree** **or** **equivalent** **international degree** **required** **.**
**Experience**
4-5years' experience in pharmaceuticalindustry,clinicalresearchorganization, or relatedrole.
Experience in Phase 2 and 3 studies and global/international studiesisadvantageous.
Experience working acrossmultipletherapeuticareas (includingoncology)isadvantageous.
**Skills**
Knowledge in global regulatory and compliance requirements for clinical research.
Demonstratedexcellence in task managementand cross-functionalcollaboration.
Excellent leadership skills.
Excellentcommunication skills.
Excellentteamwork, 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
If candidate is not eligible for any benefits or other comp., those can be excluded
**Empowering Our People to Shine**
Discover more at **takedajobs.com**
No Phone Calls or Recruiters Please.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
Massachusetts - Virtual
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
\#LI-Remote
Recommended Skills
- Attention To Detail
- Business English
- Career Development
- Clinical Research
- Clinical Works
- Contract Management
Salary : $79,000 - $114,000
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