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.
The Director, Clinical Affairs will play a critical role in supporting the CRO leadership team with business planning and execution of CRO engagements. This position will help to support the expansion of CRO operations and expertise, 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.
Responsibilities
- Collaborate with other senior Clinical Affairs leadership and executive management to develop operating objectives, organizational structure, and staffing requirements.
- Ensure clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards.
- Implement techniques to improve productivity and maintain the most up-to-date practices.
- Direct the development of department orientation and other training programs as required.
- Direct the development and communication of departmental systems, SOPs, policies, and procedures.
- Collaborate with Clinical Quality Assurance on process for CRO vendor selection, evaluation, and oversight.
- Develop and review project documents for accuracy, completeness, and compliance with company or client SOPs, GCP, and other regulatory requirements.
- Lead and direct project team to ensure that project deliverables meet client timelines.
- Approve reports and study communications generated by the project team for distribution to sponsors and investigators.
- Ensure consistency and compliance with department and company SOPs as well as departmental training manuals.
- Develop and maintain positive relationships, both internal and external to projects, including clients, team members, and site personnel (PIs, Study coordinators, etc.)
- Submit status updates to the client/sponsor as required and respond to questions and concerns.
- Ensure that departmental training needs are identified and implemented.
- Collaborate with other MCRA business units on business development initiatives, including proposal development and bid defenses.
- Serve as a clinical project manager for client projects, as needed.
- Assist with professional development for Clinical Trial Managers, Clinical Research Associates and Clinical Trial Associates.
- Represent MCRA at conferences and meetings as needed.
- Complete other duties and projects as assigned.
- Ensure all work products comply fully with SOPs, regulations, standards, policies, and the mission of MCRA.
Qualifications
- Bachelor’s degree in life sciences, health-related discipline other relevant degrees.
- 10+ years of experience in clinical trials with at least four years of supervisory clinical project management experience in a clinical research environment.
- 5+ years of medical device clinical trial experience required.
- 2+ years of experience in pharma/biologics clinical trials is preferred.
- Expert-level knowledge of decentralized trials and lessons learned from most recent execution of these trials.
- Expert-level 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.
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.