Clinical Trial Manager

The Clinical Trial Manager (CTM), reporting to Vice President of Clinical Operations, is responsible for the strategic planning, execution, and oversight of our spinal fusion clinical trials from initiation to completion. This role ensures that clinical studies are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and company policies while meeting timelines, budget, and quality objectives.

The CTM will collaborate with cross-functional teams, including clinical operations, regulatory affairs,  and data management, to drive the successful execution of trials. Responsibilities include developing study protocols, managing site selection and activation, overseeing monitoring activities, managing vendor relationships, and ensuring data integrity and study deliverables.

The ideal candidate is a detail-oriented leader with strong project management skills, a thorough understanding of clinical trial processes, and the ability to anticipate and address challenges proactively. Effective communication, problem-solving, and team-building skills are essential for ensuring trial success.

RESPONSIBILITIES:

As a Clinical Trial Manager, you will play a key role in the successful execution of clinical studies for investigational medical devices. Responsibilities include, but are not limited to:

• Protocol and Study Management:
  • Develop and manage the clinical trial protocol, as well as associated plans, timelines, and budgets.
  • Oversee all phases of the clinical trial (start-up, conduct, and close-out) to ensure study milestones are achieved.
• Cross-Functional Coordination:
  • Collaborate with internal teams such as clinical operations, data management, regulatory affairs, and quality assurance.
  • Act as a liaison between the sponsor, investigational sites, and vendors to ensure seamless study execution.
• Regulatory Compliance:
  • Ensure adherence to Good Clinical Practice (GCP), ISO 14155 (for medical devices), ethical guidelines, and applicable international and regional regulations.
  • Maintain oversight of regulatory submissions, including IRB/IEC approvals and investigational device exemptions (IDE), as applicable.
  • Stay informed about emerging regulations, industry best practices, and advances in medical device clinical research.
• Site and Vendor Oversight:
  • Manage site selection, qualification, and activation to meet enrollment targets.
  • Maintain strong communication with site staff to address issues and ensure adherence to the protocol and study requirements.
  • Oversee relationships with Contract Research Organizations (CROs), central laboratories, and other third-party vendors to ensure timely and high-quality deliverables.
• Budget and Contracts:
  • Review and negotiate budgets and contracts with investigational sites and vendors.
  • Track clinical trial budgets, manage site payments, and oversee vendor invoices.
• Risk and Issue Management:
  • Identify, assess, and mitigate risks that could affect study timelines, data integrity, or patient safety.
  • Resolve protocol deviations, non-compliance issues, and site-specific challenges.
• Monitoring and Data Integrity:
  • Ensure proper site monitoring, including initiation, interim, and close-out visits, per the monitoring plan.
  • Oversee the preparation of monitoring reports and follow up on action items with site personnel.
  • Ensure accurate and complete data collection in line with the protocol and data management plans.
  • Monitor for safety trends, adverse events, and compliance issues to ensure subject safety and data integrity.
• Training and Support:
  • Provide training to site personnel, Clinical Research Associates (CRAs), and other stakeholders on protocols, GCP, and trial-related procedures.
  • Offer ongoing guidance and support to clinical team members to enhance performance and resolve issues.
• Documentation and Quality Assurance:
  • Oversee the maintenance of the Trial Master File (TMF) to ensure completeness and audit readiness.
  • Prepare for and participate in audits and regulatory inspections, addressing findings promptly.
• Stakeholder Communication:
  • Regularly update internal and external stakeholders on trial progress through status reports and meetings.
  • Work closely with the Clinical Project Manager to track activities, ensure alignment with project plans, and manage overall trial execution.

QUALIFICATIONS:

• Bachelor’s degree or minimum of 21 hours college credit in life sciences, medical sciences, or nursing is required
  • Relevant subjects include anatomy, biochemistry, biology, biomedical science, chemistry, immunology, microbiology, molecular biology, pharmacology or pharmacy, physiology, and toxicology.
  • Additional experience in lieu of education may be acceptable
• At least five years of experience working as a CRA or in a similar capacity is required, with preference to senior supervisory roles.
• Experience in contract negotiations and budgeting at research sites as well as site initiations and close outs
• A thorough, working knowledge of Good Clinical Practices is required
• Excellent written, verbal, and interpersonal communication skills
• The ability to build effective relationships with trial center staff and colleagues
• The ability to motivate others
• Strong customer focus, presentation, and project management skills
• An excellent grasp of numeracy and a keen eye for detail
• The ability to multitask and think on your feet with a flexible and adaptable approach to work
• Organizational, IT and administrative skills - the job involves a lot of documenting and recording information through computerized processes, such as clinical trial management systems and electronic data capture
• A clean driving license may be required for travel to trial sites
• Experience in Orthopedic trials is preferred

LOCATION, TRAVEL, AND SCHEDULE

• This is a remote position, which requires infrequent travel to the company headquarters in Frederick, MD.
• This is a full-time role that will be a mixture of desk-based work and site visits. The role will operate entirely remotely when not engaged in site visits
• This role will require frequent travel throughout the US as well as some international travel.
• This position will involve close collaboration with Theradaptive partners.  Our partner companies have varying work schedules, and some evening work will be expected, although weekend or shift work will be uncommon

https://www.theradaptive.com

Theradaptive is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, ethnic or national origin, ancestry, pregnancy (including childbirth or related condition), citizenship, familial status, mental or physical disability, veteran status, genetic information, other non-disqualifying disability, or any other characteristic protected by law.