Senior Clinical Trial Manager, Cambridge, MA

5 дн. назад

USASenior

Managing clinical trials to advance life-changing medicines using AI-driven drug discovery.

Обязанности

Have the skillset and experience to execute/ manage execution of all related study start-up, maintenance and close out activities.
Demonstrates an AI-curious mindset, with an interest in exploring and leveraging emerging AI technologies to streamline contract lifecycle management and enhance operational efficiency.
Strategic and analytical thinker with excellent problem-solving capabilities and adaptability in fast-paced, matrixed environments.
Proven ability to build strong cross-functional relationships, mentor team members, and drive efficient business solutions across functional and regional boundaries.
Manage Change Orders and re-scoping with vendors and sites when necessary, including checking for accuracy of invoices and cost of services versus accruals.
Drive, contribute to and support the writing of all related clinical documents (such as the Protocol, ICF, DSUR, IB, CSR) for timely and accurate submission readiness.
Manage creation of the trial plans and their update when necessary, to ensure they remain current.
Develop (or oversee the development of) all training/ day to day materials, including SIV materials, amendment training materials, lab manuals, pharmacy manuals, and any other trial-specific training.
Support data management activities such as reviewing study-related materials created by data management, including the study manual, edit check manual, clean patient data tracker, listing review process and the Statistical Analysis Plan. 
Participate in data cleaning activities throughout the life of the trial; organize/ plan data snapshots as necessary for internal and external reviews and data deliveries.
Monitor vendor metrics and vendor performance, including KPIs, review of monitoring reports for content and compliance, deviation reporting, data cleaning activities, enrollment activities, etc.
Seek out, assess and potentially assist in onboarding potential AI solutions within this space that would prove helpful to the organization. 
Coordinate and participate in all study related meetings, including Investigator teleconferences, clinical study team meetings, vendor update calls, safety review committee meetings, data safety monitoring board, etc. as appropriate.
Assist the CRO in eTMF development and maintenance to ensure the final TMF is complete and audit ready at the close of the study.
Participate and support all audit, SOP and quality activities to ensure alignment and consistent operational excellence exist across the trial.

Будет плюсом

Prior CRA experience and/or willingness to co-monitor if needed 
Prior site experience, coordinator or other is a plus

Другое

is applying frontier AI to help unlock deeper scientific insights, faster breakthroughs, and life-changing medicines with an ambition to solve all disease.
The future is coming. A future enabled and enriched by the incredible power of machine learning. A future in which diseases are curtailed or cured starting with better and faster drug discovery. 
Come and be part of an interdisciplinary team driving groundbreaking innovation and play a meaningful role in contributing towards us achieving our ambitious goals, while being a part of an inspiring and collaborative culture.
The world we want tomorrow is the one we’re building today. It starts with the culture at this company. It starts with you. 
 
(IsoLabs) was launched in 2021 to advance human health by building on and beyond the Nobel-winning AlphaFold system. Since then, our interdisciplinary team of drug discovery experts and machine learning specialists has built powerful new predictive and generative AI models that accelerate scientific discovery at digital speed.
Our name comes from the belief that there is an underlying symmetry between biology and information science. By harnessing AI’s powerful capabilities, we can use it to model complex biological phenomena to help design novel molecules, anticipate how drugs will perform and develop innovative medicines to treat and cure some of the world’s most devastating diseases.
We have built a world-leading drug design engine comprising AI models that are capable of working across multiple therapeutic areas and drug modalities. We are continually innovating on model architecture and developing cutting-edge capabilities to advance rational drug design.
Every day, and with each new breakthrough, we’re getting closer to the promise of digital biology, and achieving our ambitious mission to one day solve all disease with the help of AI.
 
The Senior Clinical Trial Manager will fully understand and independently lead the cross-functional team through all activities within the clinical trial life cycle. These will include daily activities managing all trial start-up, conduct and close out activities to both industry and corporate standards within ICH/GCP Guidelines. The Senior Clinical Trial Manager may also have program responsibilities and managerial responsibilities, working in tandem with the Head of Clinical Operations as the department grows.
The successful candidate will have a Bachelor's Degree in a related field with a minimum of 6 years experience in the biotech and/or pharmaceutical industries. 
At least 3+ years managing oncology or rare disease trials 
Thorough understanding of GCP/ICH Guidelines, as well as strong understanding of cross-functional clinical processes 
Excellent interpersonal and communication skills for relationship building, verbal and written
Proactive problem solving, planning and project management skills are necessary 
Strong outsourced model experience, with budget management of vendors, is essential 
Ability and willingness to travel up to 30%  
We are guided by our shared values. It's not about finding people who think and act in the same way. These values help to guide our work and will continue to strengthen it. 
Thoughtful Thoughtful at Iso is about curiosity, creativity and care. It is about good people doing good, rigorous and future-making science every single day.
Brave Brave at Iso is about fearlessness, but it’s also about initiative and integrity. The scale of the challenge demands nothing less.
Determined Determined at Iso is the way we pursue our goal. It’s a confidence in our hypothesis, as well as the urgency and agility needed to deliver on it. Because disease won’t wait, so neither should we.
Together Together at Iso is about connection, collaboration across fields and catalytic relationships. It’s knowing that transformation is a group project, and remembering that what we’re doing will have a real impact on real people everywhere.
We believe that to be successful we need a team with a range of skills and talents. We're building an environment where collaboration is fundamental, learning is shared and every employee feels supported and able to thrive. We value unique experiences, knowledge, backgrounds, and perspectives, and harness these qualities to create extraordinary impact.
We are committed to equal employment opportunities regardless of sex, race, religion or belief, ethnic or national origin, disability, age, citizenship, marital, domestic or civil partnership status, sexual orientation, gender identity, pregnancy or related condition (including breastfeeding) or any other basis protected by applicable law. If you have a disability or additional need that requires accommodation, please do not hesitate to let us know.
It’s hugely important for us to share knowledge and build strong relationships with each other, and we find it easier to do this if we spend time together in person. This is why we follow a hybrid model, and would require you to be able to come into the office 3 days a week (currently Tuesday, Wednesday, and one other day depending on which team you’re in). If you have additional needs that would prevent you from following this hybrid approach, we’d be happy to talk through these if you’re selected for an initial screening call.
Please note that when you submit an application, your data will be processed in line with our privacy policy .
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