MCRA, an IQVIA business, is a leading medical device advisory firm and clinical research organization (CRO). 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 1500 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.
Position Overview
The Clinical Project Manager – Orthopedic and Spine Devices will play a critical role in the management of clinical study projects for the firm’s clientele. This position will provide oversight and management for all clinical aspects of the development and execution of clinical trials/protocols while executing Clinical Affairs functions in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.
Position Responsibilities
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 Associates.
Maintain knowledge of current GCP, FDA, and other applicable regulations.
Required Qualifications
Bachelor’s degree in healthcare or a related discipline required.
5+ years of experience in clinical trials with at least 2 years of supervisory/management experience in a clinical research environment.
Orthopedic and Spine medical device experience 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.
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.
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.
Special Requirements
Travel: 10%
Home office or DC-office based
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, an IQVIA business, 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.
