Clinical Operations Program Leader - Early Phase Neuroscience & GI (Boston, MA)
Kelly Services is currently seeking a Clinical Operations Program Leader for one of our top clients in Boston, MA.
This role will be a vital contributor to our client's Global Team. You will be empowered to oversee a robust portfolio of clinical programs and their clinical studies and collaborate with our strategic partners
. Job Responsibilities:
- Partner with the Clinical Translational Scientist to develop high quality study synopsis/protocol by providing operational input and by ensuring all relevant stakeholders (both internal and external) are involved and contributing.
- Collaborate with late phase COPL counterpart to ensure alignment and seamless interactions with the GPT.
- Maintain close communication with the Global Program Leader to ensure expectations and activities are aligned.
- Develop and lead the Early Clinical Program Operations strategy on assigned clinical programs in close collaboration with our strategic partners and with the CST.
- Perform oversight of our strategic partners to ensure the overall operational execution and delivery of the assigned clinical programs in compliance with quality standards (including ICH GCP, local regulations and Client SOPs), on schedule and on budget.
- Collaborate with cross-functional counterparts to oversee the performance for all activities assigned to our strategic partners, including escalation of issues to governance committees and to senior management when warranted.
- Is a key point of contact between the strategic partners and the GPT/CST.
- Is responsible for clinical program budget planning and accountable for external spend related to clinical program execution. Works closely with strategic partners, Global Project Management (GPM), Outsourcing Management, and Finance to ensure on a regular basis that budgets, enrolment, and gaiting are accurate.
- Communicates program status, cost and issues to ensure timely decision-making by senior management.
- Provide program-level direction and support to the strategic partners for the development of study strategy operational plans including enrolment models and risk management strategy.
- Other high level accountabilities
- Bachelor’s degree in Chemistry, Biochemistry, or related discipline. Advanced degree is highly desirable.
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP. Awareness of local country requirements is also required.
- Demonstrated excellence in project/program management and matrix leadership
- 7+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study/project management. Experience must include early phase clinical studies/Phase 2 studies and global/international studies or programs. Experience in more than one therapeutic area is highly desired.
- TRAVEL REQUIREMENTS: Requires approximately 5-20 % travel, including overnight and international travel to other client sites, strategic partners, and therapeutic area required travel.
As a Kelly employee, you’ll have access to world-class perks, including:
- Kelly-sponsored Affordable Care Act health care coverage available to eligible employees
- Group insurance options*
- Service bonus plan
- Holiday pay plan
- Weekly electronic pay options
- Online training campus that provides more than 3,000 free courses to help improve and develop skills
- Exclusive online employee community
- Employee assistance program available at no cost
- Corporate discounts
- Transportation Spending Accounts
At Kelly Services®, we work with the best. Our clients include 95 of the Fortune 100™ companies, and more than 70,000 hiring managers rely on Kelly annually to access the best talent to drive their business forward. If you only make one career connection today, connect with Kelly.
About Kelly Services®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career—connect with us today.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.