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Clinical Operations Manager Jobs in Needham, MA (NOW HIRING)

Doist

Director, Clinical Operations

Boston, MA · On-site

$215 - $240/hr

Th is individual will manage trial budgets, vendor selection, and risk mitigation while ... Performs role of Clinical Operations trial lead for assigned trials and leads cross-functional ...

inno

Clinical Operations Specialist

Middleton, MA · On-site

The COS I also manages all office and medical supplies inventory, triages incoming calls, and supports the Clinical Director, Patients Services Coordinator, and Operations Director as needed ...

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All JobsClinical Operations JobsClinical Operations Manager JobsClinical Operations Manager Jobs in Needham, MA

Clinical Operations Manager information

See Needham, MA salary details

$38.1K

$106.8K

$203.2K

How much do clinical operations manager jobs pay per year?

As of Aug 15, 2026, the average yearly pay for clinical operations manager in Needham, MA is $106,800.00, according to ZipRecruiter salary data. Most workers in this role earn between $79,000.00 and $123,600.00 per year, depending on experience, location, and employer.

What does a clinical operations manager do?

A clinical operations manager or director is a health care professional who oversees the operations of a medical facility. Their duties include meeting regularly with department heads, reading assessments of employee productivity, and managing administrative tasks, such as budgeting and billing. Qualifications for a clinical operations manager include experience in medical administration, management skills, and organizational skills. An advanced degree in public health or health administration can significantly improve your job opportunities.

What is the difference between Clinical Operations Manager vs Clinical Research Coordinator?

AspectClinical Operations ManagerClinical Research Coordinator
CredentialsBachelor's degree in health sciences, management experienceBachelor's degree in health or life sciences, research training
Work EnvironmentOversees multiple clinical trials, manages teamsAssists with daily trial activities, data collection
Employer & IndustryPharmaceutical companies, CROs, hospitalsResearch institutions, hospitals, clinical sites

The Clinical Operations Manager focuses on overseeing entire clinical trial operations, managing teams, and ensuring compliance. In contrast, the Clinical Research Coordinator handles the day-to-day activities at trial sites, such as patient recruitment and data collection. Both roles require related credentials and work within the clinical research industry, but their responsibilities and scope differ significantly.

How much do clinical operations managers make?

Clinical operations managers in the US typically earn between $80,000 and $130,000 annually, with the median salary around $105,000. Compensation varies based on experience, location, and the size of the organization, and often includes benefits such as health insurance and bonuses.

What are the key skills and qualifications needed to thrive as a clinical operations manager, and why are they important?

To thrive as a Clinical Operations Manager, you need expertise in clinical trial management, regulatory compliance, and healthcare operations, usually supported by a degree in a health-related field and relevant experience. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) platforms, and certifications such as ACRP or SOCRA are commonly required. Strong leadership, problem-solving abilities, and effective communication are essential soft skills for this role. These skills ensure efficient trial execution, regulatory adherence, and successful coordination across teams and stakeholders.

What are the main challenges clinical operations managers face when overseeing multiple clinical trials simultaneously?

Clinical Operations Managers often juggle several clinical trials at once, which can present challenges such as maintaining consistent quality across studies, ensuring timely patient recruitment, and managing diverse teams. They must coordinate with cross-functional departments, address regulatory compliance, and troubleshoot unforeseen issues, all while staying on schedule and within budget. Effective organizational skills, proactive communication, and adaptability are essential for overcoming these challenges and ensuring successful trial outcomes.

What is a clinical operations manager?

Clinical Operations Managers are professionals responsible for overseeing the day-to-day administrative and operational functions of clinical trials or healthcare facilities. They ensure that clinical protocols are followed, resources are efficiently allocated, and regulatory compliance is maintained. These managers coordinate between healthcare staff, researchers, and external partners to facilitate smooth clinical operations and high-quality patient care. Their role is essential in ensuring that clinical services or trials are delivered effectively, safely, and on schedule.
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Clinical Operations Manager jobs near you

Director, Clinical Operations

Oruka Therapeutics

Waltham, MA • On-site

Full-time

Re-posted 17 days ago

Job description

About Us:
Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com
As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
Job Title: Director, Clinical Operations
Location: Waltham, MA Hybrid - onsite 3 days/week required
Reports To: Vice President, Clinical Operations
Role Overview:
We are seeking an exceptionally nimble and flexible Director of Clinical Operations who has a track record of achievement across all aspects of trial setup and execution in a fast paced small biotech with limited infrastructure and resources. The individual will successfully lead and optimize activity across multiple studies for Oruka Therapeutics. This critical role demands a strategic leader who possesses a keen ability to "zoom in" on intricate operational details while simultaneously "zooming out" to maintain a holistic view of program progress and timelines The successful candidate will be a proactive problem-solver, adept at navigating complexities, anticipating challenges, and implementing agile solutions to ensure our clinical trials remain on schedule and within budget. We are looking for a candidate that can demonstrate a high degree of integrity, pragmatism and is laser focused on commitment to study goals. You should be comfortable being a 'player/coach' taking on tactical tasks as required in support of the program.
Key Responsibilities:
  • Strategic Oversight & Agility in Clinical Study Planning, Management and Execution:
    • Develop and implement strategic operational plans for clinical trials, ensuring alignment with program goals and business objectives.
    • Proactively identify potential risks, bottlenecks, and deviations from timelines, and swiftly implement corrective actions with a flexible and adaptable approach.
    • Demonstrate the ability to rapidly assess evolving circumstances (e.g., regulatory changes, unexpected site challenges, vendor issues) and adjust operational strategies accordingly.
    • Maintain a high-level overview of all assigned clinical trials, understanding interdependencies and potential impacts on overall program timelines.
  • Operational Excellence & Detailed Focus in Conducting Clinical Trials:
    • Provide expert operational guidance and oversight for all phases of clinical trials, from study startup through close-out.
    • Possess the ability to delve into granular operational details when necessary to identify root causes and inform strategic decisions.
    • Ensure adherence to Good Clinical Practice (GCP), regulatory requirements, Standard Operating Procedures (SOPs), and company policies.
    • Oversee the selection, qualification, and management of Contract Research Organizations (CROs) and other third-party vendors, ensuring their performance meets expectations and timelines.
    • Maintain oversight of clinical operations budgets, including regular forecasting and internal reporting to management and finance
    • Support supply chain planning and management with both clinical and non-clinical supplies for trial execution.
  • Timeline Management & Proactive Problem Solving in Executing Clinical Trial Programs:
    • Lead and manage clinical trial timelines, ensuring key milestones are met and proactively mitigating any delays.
    • Implement robust tracking and reporting mechanisms to monitor trial progress and identify potential deviations early.
    • Develop and execute contingency plans to address unforeseen challenges and keep trials on track.
    • Facilitate effective communication and collaboration across cross-functional teams to drive trial progression.
  • Operate as a "Hands-On" Leader & Develop Teams in a Fast-Paced Environment:
    • We need a hands-on leader who can contribute individually to deliverables and meet deadlines to hit ORUKA milestones.
    • Foster a culture of accountability, continuous improvement, and proactive problem-solving within the clinical operations group.
    • Represent Clinical Operations in internal and external meetings, contributing to strategic discussions and decision-making.

Qualifications:
  • BA/BS required in a scientific/medical field preferred
  • A minimum of 10+ years of experience in managing global clinical trials at all stages of development
  • Experience in immunological and dermatologic disease areas welcome
  • Capable of managing direct reports from afar and study team members across multiple time zones and cultures
  • Demonstrated ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking and reporting activities
  • Demonstrated successful management and oversight of CROs and other service providers
  • Deep understanding of clinical trial design, protocol development/ review, and running the clinical trial meetings
  • Significant experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities
  • Strong vendor management experience required
  • Experience in the management and maintenance of EDC, CTMS, IRT, ePRO, etc.
  • Experience with Quality Assurance, SOP and Study Plans writing, CAPA preparation, and closure
  • Experience with a submission-ready eTMF, regulatory inspections and/or inspection-readiness activities
  • Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations
  • Strong project management experience and skills is preferred
  • Demonstrate strong leadership, collaboration and cross-functional management skills, ability to multi-task in a dynamic and fast-paced environment
  • Strong interpersonal, negotiation, influencing, problem-solving skills
  • Excellent written and verbal skills required
  • Willing to travel domestically and internationally up to 25% of the time
  • Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
  • Strong computer and database skills
  • Clear and concise oral and written communication skills
  • Excellent organizational skills and experience prioritizing conflicting demands
  • Critical thinking, problem solving, ability to work independently.
  • Consistently operate with urgency, clarity and conciseness
  • Communicate effectively and articulate complex ideas in an easily understandable way

Compensation:
  • An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
  • The anticipated salary range for candidates is $213,000 - $240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.

Location: Waltham, MA Hybrid - onsite 3 days/week required
Salary Range for the Role
$213,000-$240,000 USD
What We Offer:
  • A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
  • Competitive salary and benefits package.
  • A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
  • Opportunities for professional growth and development.

Apply