Clinical trial manager job description

Requirements

Required Education/Experience:
- Bachelor's Degree in biological sciences or health-related field.
- Minimum of five (5) years' experience as a clinical research associate or equivalent position, including at least two (2) years managing clinical studies for a sponsor organization, or equivalent application of research methodology in a clinical research setting.
- Experience leading teams in a matrixed environment.
- Experience in Phase 1 & 2 clinical research.
- Experience developing study materials (eg, protocols, plans, manuals).
- Experience evaluating site performance against established criteria.

Preferred:
- Seven (7) years of related experience in an FDA-GCP regulated industry.
- Clinical Research Associate certification.
- Masters Degree in biological sciences or health-related field.
- Experience managing complex oncology clinical trials.
- Experience managing vendor(s), eg,Contract Research Organization (CRO).
- Experience managing pediatric clinical trials.
- Experience working in an academic setting.
- Experience working with Lean or Six Sigma principles.

In accordance with new Washington law for healthcare workers, Seattle Children's requires that all staff be fully vaccinated against COVID-19 on or before October 18, 2021, or before beginning employment for start dates after October 18th.

About Us

Hope. Care. Cure. These three simple words capture what we do at Seattle Children's - to help every child live the healthiest and most fulfilling life possible. Are you ready to engage with a mission-driven organization that is life-changing to many, and touches the hearts of all? #HOPECARECURE

As one of the nation's top five pediatric research centers, Seattle Children's Research Institute is dedicated to providing hope, care, and cures to help every child live the healthiest and most fulfilling life possible.

Our investigators are involved in hundreds of projects that cover every phase of research, from studying how diseases work to improving investigational therapies. They have pioneered groundbreaking cystic fibrosis treatments and cutting-edge cancer therapies that help a child's immune system defeat cancer, and made other major contributions to pediatric medicine.

Researchers work in close collaboration with one another, their colleagues at partner institutions including the University of Washington and Fred Hutch and our healthcare providers at Seattle Children's Hospital, one of U.S. News & World Report's top children's hospitals. This collaboration is one of our key strengths, allowing our faculty to draw on a variety of disciplines and techniques as they pursue solutions to some of medicine's most complex problems.

We are committed to not only treating disease but to eliminating it. Help us achieve our vision of being a worldwide leader in pediatric research aimed to improve the health and well-being of children. If you are interested in a challenging career aimed at groundbreaking research, Seattle Children's Research Institute is the place for you.

Covid-19 Vaccination In accordance with Washington state law, Seattle Children's requires that all employees be fully vaccinated against COVID-19. All offers are contingent and your vaccine status will be verified at onboarding. Our Commitment to Diversity

Our community welcomes diverse experiences, backgrounds, and thoughts as this is what drives our spirit of inquiry and allows us to better connect with our increasingly diverse patients and families. Our organization recruits, employs, trains, compensates, and promotes without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

The people who work at Seattle Children's are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves within this community, which cultivates and promotes equity, diversity, and inclusion at all levels.

Seattle Children's is proud to be an Equal Opportunity Workplace and Affirmative Action Employer.

About This Role
Make the most meaningful impact of your career in this rewarding role with Biogen, an established pioneer in biotechnology. This is your rare opportunity to begin transcending out of day-to-day management operations as you design operational strategy and oversee our clinical research organization (CRO) partners to provide operational input into the development of clear protocol concepts and final protocols. The best part: You will own or share responsibility for entire clinical trial studies, including operational design, successful delivery, and the positive impact on the lives of patients with a wide array of neurological conditions, including multiple sclerosis (MS), Alzheimer's disease, and spinal muscular atrophy (SMA). Working from home, office, or both on a flexible, hybrid schedule, you'll have the support of a team with well-established procedures in place to make your vision a reality.

This is a hybrid (part-time on-campus) opportunity, with full-time remote work considered.

What You'll Do

Independently or in conjunction with other study CTLs (Sr. Manager/AD), develop and oversee implementation of the study-level operational strategy for the successful delivery of clinical studies.

Chair the Study Management Team (SMT) to drive development of scientifically robust, operationally feasible, and clear concepts/protocols.

Oversee delivery of studies by CROs to ensure quality execution in line with time and budget forecasts.

Partner with the CRO SMT lead to ensure the CRO creates appropriate risk-mitigation plans and effectively identifies/resolves issues.

Establish and drive efficient team operations by establishing an open culture defined by communication, goal setting, and oversight of strategy implementation.

Ensure effective, consistent, efficient and compliant processes.

Who You Are
Scientifically and clinically astute, you're a mission-driven individual with the strategic vision to see the big picture and assume responsibilities much broader and more meaningful than day-to-day operations. Decisive, analytical and self-confident, you are determined to own all of your career and the difference you can make on the lives of others through your leadership and ability to inspire excellence.

Responsibilities
Here is a unique opportunity - Seattle Children's is building a Therapeutics core to support our mission to provide novel treatments to children. Our vision is to implement a pediatric nonprofit biotech business model to carry this treatment from bench to bedside efficiently and effectively. Under supervision, the Trial Manager will coordinate and manage the planning, implementation and completion of single and multi-site clinical trials for Seattle Children's Immunotherapy Integration Hub. Ensure research projects are conducted in compliance with applicable federal and local regulations, ICH/GCP, organization policies, and institutional/ departmental guidelines. Manage and monitor clinical sites, and oversee vendor activities as assigned. Development and maintain study documents including protocols, plans, manuals, subject materials and forms. Support trials to meet determined timelines for key milestones and deliverables. Identify and implement process improvement ideas in collaboration with department staff. Assist with development of department infrastructure as required. We are a team of strong people who care deeply about the work we do and try to have fun doing it!
Under supervision, coordinate and manage the planning, implementation and completion of single and multi-site clinical trials for Seattle Children's Immunotherapy Integration Hub. Ensure research projects are conducted in compliance with applicable federal and local regulations, ICH/GCP, organization policies, and institutional/ departmental guidelines. Manage and monitor clinical sites, and oversee vendor activities as assigned. Development and maintain study documents including protocols, plans, manuals, subject materials and forms. Support trials to meet determined timelines for key milestones and deliverables. Identify and implement process improvement ideas in collaboration with department staff. Assist with development of department infrastructure as required.
Requirements
Required Education/Experience: -Bachelor's Degree in biological sciences or health-related field or equivalent experience.
- Minimum of two (2) years' experience as a clinical research associate or equivalent position, including at least one (1) year managing clinical studies for a sponsor organization, or equivalent application of research methodology in a clinical research setting. - Experience working in a matrixed environment. - Experience in Phase 1 & 2 clinical research. - Experience developing study materials (eg, protocols, plans, manuals). - Experience evaluating site performance against established criteria. Required Credentials: N/A Preferred: - Five (5) years of related experience in an FDA-GCP regulated industry. - Clinical Research Associate certification. - Masters Degree in biological sciences or health-related field. - Experience with complex oncology clinical trials. - Experience working with vendor(s), eg,Contract Research Organization (CRO). - Experience with pediatric clinical trials. - Experience working in an academic setting. - Experience working with Lean or Six Sigma principles.
In accordance with new Washington law for healthcare workers, Seattle Children's requires that all staff be fully vaccinated against COVID-19 on or before October 18, 2021, or before beginning employment for start dates after October 18th.
About Us
Hope. Care. Cure. These three simple words capture what we do at Seattle Children's - to help every child live the healthiest and most fulfilling life possible. Are you ready to engage with a mission-driven organization that is life-changing to many, and touches the hearts of all? #HOPECARECURE
As one of the nation's top five pediatric research centers, Seattle Children's Research Institute is dedicated to providing hope, care, and cures to help every child live the healthiest and most fulfilling life possible.
Our investigators are involved in hundreds of projects that cover every phase of research, from studying how diseases work to improving investigational therapies. They have pioneered groundbreaking cystic fibrosis treatments and cutting-edge cancer therapies that help a child's immune system defeat cancer, and made other major contributions to pediatric medicine.
Researchers work in close collaboration with one another, their colleagues at partner institutions including the University of Washington and Fred Hutch and our healthcare providers at Seattle Children's Hospital, one of U.S. News & World Report's top children's hospitals. This collaboration is one of our key strengths, allowing our faculty to draw on a variety of disciplines and techniques as they pursue solutions to some of medicine's most complex problems.
We are committed to not only treating disease but to eliminating it. Help us achieve our vision of being a worldwide leader in pediatric research aimed to improve the health and well-being of children. If you are interested in a challenging career aimed at groundbreaking research, Seattle Children's Research Institute is the place for you.
Covid-19 VaccinationIn accordance with Washington state law, Seattle Children's requires that all employees be fully vaccinated against COVID-19. All offers are contingent and your vaccine status will be verified at onboarding.
Our Commitment to Diversity
Our community welcomes diverse experiences, backgrounds, and thoughts as this is what drives our spirit of inquiry and allows us to better connect with our increasingly diverse patients and families. Our organization recruits, employs, trains, compensates, and promotes without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
The people who work at Seattle Children's are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves within this community, which cultivates and promotes equity, diversity, and inclusion at all levels.
Seattle Children's is proud to be an Equal Opportunity Workplace and Affirmative Action Employer.PDN-9628e4dd-1f6c-4335-931c-9f593012110b