Associate Clinical Trial Leader (Cambridge, MA)
Associate Clinical Trial Leader (Cambridge, MA)
Job Description1 purpose...to reimagine medicine!
As an Associate Clinical Trial Leader (aCTL) you will be responsible for supporting, under the guidance of the Lead Clinical Trial Leader and/or Clinical Trial Leader (CTL) and the Clinical Program Leader (CPL), all aspects of TCO clinical trial(s) as assigned.
Your Responsibilities include but are not limited to:
1. Support the clinical protocol development process in collaboration with the CTL/Lead CTL and the Clinical program Leader (CPL): contribute in the development of clinical protocols, amendments and related documents; drive and/or contribute to the development of trial-related documents and processes.
2. Investigator/site relationship management is vital; support CTL/Lead CTL and CPL in developing effective working relationships with investigators. Support protocol training meetings and support CPOs in regulatory submission preparation and the conduct of regional meetings.
3. Support the CTL/Lead CTL, in the ongoing review and cleaning of the clinical trial data.
4. Support the CPL/CTL or Lead CTL in preparing dose escalation meetings with investigators. Under the supervision of the CTL/Lead CTL coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, imaging and biomarker data, to provide consolidated information for dose escalation meetings with investigators.
5. Attend relevant meetings to support ongoing execution of clinical trial and program level activities.
6. Under the guidance of the CTL/Lead CTL develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties including central lab and imaging vendors.
7. Support the implementation of best practices and standards for trial management, including sharing lessons learned.
8. Support/drive the maintenance of simple studies/studies in closeout phase or ongoing studies post primary database lock with the oversight of the LCTL/CTL, as assigned.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Minimum requirementsMinimum requirements :
What you’ll bring to the role:
• Must have a Bachelor degree or equivalent education/degree qualification in life science/healthcare required if accompanied by at least 2 years of involvement with clinical study planning, execution, reporting and publishing activities (either at a local medical organization, investigational site, pharmaceutical company/CRO, or clinical fellowship program).
• Good communication, organization and tracking skills.
• Basic knowledge of Good Clinical Practice; basic knowledge of scientific principles.
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network