Clinical Operations Clinical Trial Manager – Bluewing Study-Kelly Bedford, Massachusetts

Orbis Clinical is seeking a Clinical Trial Manager (CTM) – Bluewing Study in Bedford, MA (Hybrid role) for 6 months.

Client is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using client’s proprietary approach, the company is developing antisense oligonucleotides (ASOs) to selectively restore naturally occurring protein levels.  

Client’s initial focus is on diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for the Company’s proprietary approach. 

Position Purpose:

(Bluewing; Adult study) – this person would be supporting a Sr. CTM on a global study working in an outsourced model (i.e. overseeing CROs and vendors), as well as managing vendors, with a focus on study start up and vendor/system/functional integration. Ideally, this candidate would have rare disease experience (preferable, not required). 

Key Responsibilities:

• Work in a matrix management organization, responsible for leading and managing all aspects of assigned clinical study(ies) (i.e. Phase 1-3, Open Label Extensions) with partner CROs and vendors, by ensuring assigned studies are conducted according to timelines and budget per the Clinical Development Plan (CDP).
• Assume a lead role in the identification process of Investigators and vendors and oversight of clinical site and vendor qualification prior to study execution. 
• Provides input into clinical study protocols, informed consent forms (ICFs) and other clinical study documents.
• Develop and oversight of study operational plans to ensure study compliance and quality is maintained. 
• Oversees the development of and adherence to clinical study timelines as per the Clinical Development Plan (CDP) and collaborates with internal functional stakeholders for alignment.
• Proactively identify study risks and coordinate risk identification and mitigations with the study team, CRO and vendors. 
• Coordinates the relevant and timely exchange of study status with internal functional stakeholders to support clinical study delivery per the CDP.
• Coordinates with CMC regarding drug forecasting and supply of drug products to sites. 
• Supports timely and efficient database lock by ensuring monitoring plans are in place and by participating in data review / reconciliation efforts.
• Adheres to clinical study budgeting process and provides input to finance on budget accruals and forecasts.
• Participates in clinical study scenario planning (estimates timelines and cost) with support and alignment with the Director, Clinical Operations.
• Utilizes project management skills to ensure consistency in processes and drive Clinical Operations performance. 
• Demonstrates a high level of knowledge of clinical operations’ methodologies, organizational, project management and study team leadership capabilities.
• Actively participates in the development of department initiatives, including the development /definition of SOPs and processes. 

Required Skills & Experience: 

• Strong knowledge of ICH-GCP guidelines and regulations.
• Strong knowledge of the Drug Development process
• Bachelor’s degree or higher in a scientific or healthcare discipline preferred.
• Minimum of 4-6 years of progressive experience in clinical operations within biotech, pharmaceutical, CRO industry or equivalent clinical research experience.
• Experience conducting and/or overseeing PSVs, SIVs, IMVs, and COVs required. 
• Rare Disease and Neurology clinical study experience are highly desirable.
• Proficiency in Microsoft Word, Excel, Outlook, PowerPoint, and MS Project
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced start-up environment consisting of internal and external team members.
• An analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills include the ability to support and prioritize multiple projects.  

Culture & Values:

Client believes that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual’s needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.

Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do. 

Location(s): 

• Client is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This position is remote, with the ability to be in the office when needed, currently based in Bedford and will later be based in Waltham.

Travel:

• This position will require approximately 0 travel. 

Compensation Details:

• Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location. 
• The Pay Range for this position is $60.00-$79.00 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). .

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.