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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.
Responsibilities
- Participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for, multiple service, multiple country and/or multi regional studies. Understand project strategy and operationalize the agreed upon approach.
- Develop integrated study management plans with the core project team.
- Accountable for the strategic planning and execution of clinical studies as per the contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
- Set objectives of the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
- Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
- Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally.
- Responsible for delivery and management of medium to large sized, multiple and full service, multi regional studies.
- Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
- Achieve project quality by identifying quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans.;
- Serve as primary project contact with customer and own relationship with the project’s key customer contact(s)
- Communicate/collaborate with IQVIA business development representatives as necessary.
- Build the cross-functional project team and lead their efforts, responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
- Ensure the financial success of the project.
- Forecast and identify opportunities to accelerate activities to bring revenue forward.
- Identify changes in scope and manage change control process, as necessary.
- Identify and communicate lessons learned and best practices to promote continuous improvement.
- Adopt corporate initiatives and changes and serve as a change advocate when necessary.
- Provide input to line managers of their project team members’ performance relative to project tasks. Support staff development.
- Mentor less experienced project team members on assigned projects to support their professional development.
Qualifications
- Bachelor's Degree Life sciences or related field Req
- 5+ years of experience supporting IVD/Neuro device trials
- Requires greater than 7 years clinical research experience including 4 years project management experience or equivalent combination of education, training and experience. Req
- Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.; Req
- Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge, therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.;
- Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills.
- Communication - Requires strong negotiation and customer management skills.
- Problem solving - Strong problem solving skills.
- Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross
- functionally and with customers to advance work effectively and efficiently.;
- Organization - Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.;
- Leadership - Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
- Prioritization - Ability to handle conflicting priorities. Ability to work strategically to realize project goals, identifying and developing positive and compelling visions for the successful delivery of the project.
- Quality - Attention to detail and accuracy in work.
- Quality - Results-oriented approach to work delivery and output. Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.
- IT skills - Good software and computer skills, including MS. Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
- Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients. Excellent customer service skills and demonstrated ability to understand customer needs. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
- Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences. Good understanding of other IQVIA functions and their inter-relationship with Project Leadership.
- Finances - Good understanding of project financials including experience managing, contractual obligations and implications.
$140,000 - $150,000 a year
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.
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