Founded in 2004, MCRA is a leading medical device, biologics, and diagnostics CRO and advisory firm. MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. MCRA's integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, drug/device combination products, and in vitro diagnostic (IVD) devices.
The Clinical Trial Manager will play a critical role in supporting the execution of CRO engagements with a particular focus on the execution of clinical trials for clients products in the pharmaceutical, biotech, or combination product spaces. This position will help to support the expansion of CRO operations and expertise in drug studies, provide oversight and management for all aspects of the development and execution of clinical trials/protocols, and execute Clinical Affairs functions in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.
- Ensure that studies are conducted according to the study protocol, SOPs, ICH/GCP regulations and study-specific manuals and procedures.
- Lead and direct project team to ensure deliverables meet project timelines.
- Track and report on progress of study including site activation, patient enrollment, and monitoring visits.
- Develop Clinical Monitoring Plan and other project documents as assigned.
- Oversee all clinical monitoring activities for clinical studies, including remote monitoring and remote site management.
- Approve reports and study communications generated by the project team for distribution to sponsors and investigators.
- Ensure Trial Master File is accurate and complete throughout the lifecycle of the project.
- Oversee study vendors, when applicable.
- Provide ongoing study training to the clinical project team.
- Develop and maintain positive relationships both internal and external to projects, including clients, team members, and site personnel (PIs, Study coordinators, etc.)
- Assist with professional development for Clinical Research Associates and Clinical Trial Associates.
- Maintain knowledge of current GCP, FDA, and other applicable regulations.
- Bachelor's degree in healthcare or a related discipline required.
- 5+ years of experience in clinical trials with at least 2 years of supervisory experience in a clinical research environment.
- 3-5+ years of IND clinical trial experience, specifically phase III and/or phase II trials required.
- Knowledge of clinical project management, GCPs, and clinical monitoring procedures.
- Demonstrated ability to manage multiple clinical studies simultaneously.
- Understanding of therapeutic area for assigned clinical projects.
- Experience using Electronic Data Capture (EDC) and clinical trial management systems for project management and monitoring.
- Must be a talented consensus builder and team player with the ability to engage and influence a multi-functional team
- Ability to manage clients independently.
- Must be able to coach a diverse group of employees, identify critical milestones, and hold teams and individuals accountable for strategic objectives and tactical execution
- Must be able to manage multiple projects and deliverables simultaneously and generate meaningful results.
- Ability to adapt to a rapidly changing environment and quickly identify new trends and changes specific to the industry.
- Advanced Proficiency with MS Office Suite (Outlook, Word, Ppt, Excel) and internet applications.
- Excellent organization and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.
- Excellent oral and written communication skills.
- Experience working with C-Level and senior management.
- Expertise in department and personnel management.
- Supervisory responsibilities
- Ensure work meets client and company standards.
- Assisting with hiring and training of qualified candidates.
- Oversee the day-to-day workflow of assigned clinical staff.
- Conduct performance evaluations that are timely and constructive.
- Travel: 0-20% to our offices, and for meetings and conferences
- Home office or DC-office based
Compensation & Benefits
- Salary + bonus
- Medical, dental, and vision insurance
- Company-paid life insurance
- Company-paid STD and LTD
- Generous PTO policy
- Fully paid maternity leave benefits
- Pre-tax public transit and parking benefit
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.
MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.