Clinical Project Manager
Boston, MA
Full Time
Clinical Operations
Experienced
Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the care of people living with rare melanocortin-4 receptor (MC4R) pathway diseases. Working at Rhythm means that you are part of a team that’s passionate about transforming the lives of people living with hyperphagia (pathological, insatiable hunger) and severe obesity caused by rare MC4R pathway diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
Rhythm seeks an experienced and highly motivated individuals to join its team in Boston, Massachusetts. Within the clinical operations group, there are multiple ongoing and planned studies designed to develop innovative therapies for people with rare neuroendocrine diseases. The position will be responsible for overseeing components of study execution and as such will routinely interact with the medical, translational research, regulatory, biostats and diagnostic groups to ensure deliverables are met.
Responsibilities and Duties
Qualifications and Skills
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm our core values are:
Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.
Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the care of people living with rare melanocortin-4 receptor (MC4R) pathway diseases. Working at Rhythm means that you are part of a team that’s passionate about transforming the lives of people living with hyperphagia (pathological, insatiable hunger) and severe obesity caused by rare MC4R pathway diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
Rhythm seeks an experienced and highly motivated individuals to join its team in Boston, Massachusetts. Within the clinical operations group, there are multiple ongoing and planned studies designed to develop innovative therapies for people with rare neuroendocrine diseases. The position will be responsible for overseeing components of study execution and as such will routinely interact with the medical, translational research, regulatory, biostats and diagnostic groups to ensure deliverables are met.
Responsibilities and Duties
- Manage integrations of all clinical study activities leveraging internal and CRO resources, expertise and knowledge
- Provide trial cost estimates and timelines as part of CDP development
- Drive execution of clinical trials from protocol design to the final clinical study report for specified studies.
- Effectively communicate with Key Opinion Leaders
- Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day-to-day operational management activities of CROs
- Oversight of study quality and GCP compliance
- Assist in the development of contingency/risk management plans and associated mitigation strategies
- Oversee and coordinate with document specialists regarding study files and Trial Master File (TMF) quality checks, including oversight of junior team members
- Prepare budgets, timelines, and forecasts for assigned clinical studies
- Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance and Medical Affairs to align on deliverables and execute study activities
- Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure
Qualifications and Skills
- BA/BS degree, advanced degree preferred
- 5+ years of relevant experience within a CRO, pharmaceutical, and/or biotech company
- Experience working on Phase I - IV multinational clinical studies
- Regulatory knowledge, including Good Clinical Practices (GCPs)
- Knowledge of global clinical trial management in CRO outsourced environment
- Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability
- Excellent communication skills (written and verbal)
- Ability to assemble a plan and execute on the details
- Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project
- Able to travel (annual average of 10 – 20%)
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm our core values are:
- We are committed to advancing scientific understanding to improve patients’ lives
- We are inspired to tackle tough challenges and have the courage to ask bold questions
- We are eager to learn and adapt
- We believe collaboration and ownership are foundational for our success
- We value the unique contribution each individual brings to furthering our mission
Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.
Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.
Apply for this position
Required*