Clinical Research Associate Manager (REMOTE)

Position Summary

The CRA Manager will provide leadership, oversight and operational direction to a team of in-house and regional Clinical Research Associates (CRAs). This individual has knowledge and experience managing study activities from site selection, start-up, to close-out with adherence to regulations, maintaining data integrity, and aligning deliverables with corporate goals. As a key contributor to the Global Clinical Operations team, this position develops and assesses SOPs, assesses processes for efficiency and compliance. This position requires the ability to be detail-oriented, organized, and productive with a keen interest in medical device and biologics research.

Principal Responsibilities

•    Manage a team of in-house and regional CRAs, providing guidance on study conduct, clinical operational and monitoring strategy, as well as professional growth.
•    Serve as primary point of contact for CRA escalations and issue resolution across assigned studies.
•    Partner with Clinical Project Managers and cross functional teams to support all phases of a clinical study including protocol, CRF, and monitoring plan development, essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools.
•    Conducts Qualification, Site Initiation, Interim, and Close-Out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations.
•    Train site personnel regarding the protocol and applicable regulatory requirements.
•    Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment.
•    Lead study meetings to ensure completion of established project team goals and objectives, including study training and data review.
•    Facilitate corrective action assessment and maintain TMF in BIMO readiness.
•    Provide study status updates to Management team and develop sufficient resolution of identified action items.
•    Contribute to annual reports, data management, data analysis, and publication support.
•    Develop and assesses SOPs annually, as needed.
•    Maintain current knowledge of applicable US and international clinical regulations and guidance documents.
•    Participate in department systems and development initiatives including related trainings.
•    Support investigator meetings as needed.
•    Support Protocol Deviation and Adverse Event review and reporting.
•    Maintain credentialing requirements at hospitals and clinics as needed.
•    Complete projects and tasks consistent with corporate objectives.
•    Support the Clinical Operations team in general and with various improvement projects.
•    Perform other duties as assigned.

Education / Experience Requirements

•    Bachelor of Science degree preferably in natural sciences or related field, or related practical experience.
•    Minimum 8 years of clinical research experience, medical device experience preferred. This should includes a minimum of 3 years in a CRA management, or lead CRA capacity.
•    Proficient in Microsoft Word and Excel, and the ability to quickly learn other software tools and applications, such as Access, etc.
•    US IDE, IND, and OUS experience preferred.

Specialized Skills / Other Requirements

•    Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action.
•    Excellent time management skills.
•    Ability to recognize potential obstacles and develop solutions to resolve them with minimal consequence within set timelines or change direction if priorities are modified.
•    Ability to make critical, independent decisions and be accountable for actions within a fast-moving environment.
•    Ability to perform at high-level with limited supervision and effectively partner with team members when necessary.
•    Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria.
•    Ability to develop strong relationships with investigative sites.
•    Excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
•    Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
•    Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings. 

CULTURE:
•    Customer Experience – Representing Teleflex in a customer-facing position is a tremendous responsibility and opportunity. All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics to strengthen the Teleflex brand and relationship with our customers. 
•    Continuous Improvement - Demonstrates initiative and critical thinking to identify and prioritize process and performance gaps. Develops solutions to deliver improving results. Exemplifies continuous improvement of thought processes and focus. 
•    Culture and Values – Exemplifies Teleflex values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant. Strives to work effectively across boundaries in a complex matrix environment. Lead and participate in the process of promotional and other materials, working 
internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data.

TRAVEL REQUIRED: 50-75% (US and Internationally) 

The pay range for this position at commencement of employment is expected to be between $125,700- $188,600 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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