Senior Clinical Trial Associate/Lead Clinical Trial Associate
Company: Takeda Pharmaceuticals
Location: Albany
Posted on: January 27, 2023
Job Description:
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to the best of my knowledge.Job DescriptionSr Clinical Trial
AssociateAre 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.OBJECTIVESThe
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
- Bachelors 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 ProgramsLocation 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 excludedEmpowering Our People to ShineDiscover more at
takedajobs.comNo Phone Calls or Recruiters Please.EEO
StatementTakeda 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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time#LI-Remote
Keywords: Takeda Pharmaceuticals, Albany , Senior Clinical Trial Associate/Lead Clinical Trial Associate, Healthcare , Albany, New York
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