- Administratively manages CRAs based in and out of Americas. Responsible for training new CRAs and continuous training of current CRAs and ensures appropriate training is documented. Conduct training trips with new CRAs during on-boarding and may co-travel with CRAs for re-training, co-monitoring, to ensure monitoring practices are being followed, and/or assist monitors with addressing issues at sites, as needed.
- Responsible for setting the standard for the CLINICAL AFFAIRS department on good monitoring practices and study documentation per Insightec SOPs/processes and applicable regulations.
- Responsible for training all appropriate CLINICAL AFFAIRS personnel on Insightec practices and procedures for study monitoring and study documentation.
- Continually assess and maintain internal CRA training materials for all monitoring activities. Ensure personnel are up to date with required training and provide additional training, as needed. Together with Ass Directors, identify other training opportunities across the CLINICAL AFFAIRS group.
- Collaborate with internal/external stakeholders to ensure CRAs deliver high quality study data and monitoring visit reports within required timelines.
- Collaborate /Assist Ass. Directors and Clinical Project Managers (CPM) with oversight, study specific documentation review and QC including review of ICF, study plans, study reference manuals, eCRF, etc. as needed.
- Collaborate/Assist Database Manager with database structure to enhance monitoring activities and or in its validation, as needed.
- Collaborate/Assist Database Manager with Trial Master File (TMF) by identifying risks and ensuring compliance with internal and regulatory requirements. Proactively generate, monitor, and analyze TMF performance metrics and trends, and collaborate with the trial team to ensure the completeness and accuracy of the TMF.
- Together with Ass. Directors will designate CRA study protocol assignments and manage CRA workload.
- Together with QA team, will ensure consistency in CRA processes and practices across all geographies, consistent with local global regulations.
- Ensure monitoring documents and processes are in compliance for each study performed by Insightec and as consistent as possible across studies.
- Will function as a resource within the global CLINICAL AFFAIRS department for best practices and problem-solving monitoring/QA issues.
- Will work with Manager of Regulatory, Ass. Directors and their teams to create/review/ revise/update department SOPs, work instructions and processes based upon differences in local/global regulatory requirements.
- Will plan and conduct / delegate site audit responsibilities. This will include assisting sites in preparation for possible/pending regulatory audits. This position may also help/consult with sites on responses to 483's (and similar terminology for other regulatory agencies).
- Will work with SVP Regulated Clinical Affairs, Manager of Regulatory, and/or Ass. Directors to prepare for Sponsor/Regulatory site audits. Will work with CLINICAL AFFAIRS management to address any issues identified.
- Manage and develop professional relationships with investigational site personnel and investigators involved in study(ies) with Insightec to ensure appropriate stakeholder engagement and support.
- Manage internal company relationships/expectations and maintain open communication to successfully meet all study goals.
- Collaborate with all stakeholders to ensure high standards (and audit-readiness) are maintained across all studies in all geographies.
- At least 7-10 years relevant industry experience in clinical research environment as well as in mana.
- Approximately 30% travel that will vary over time, including international travel to other countries (Position requires valid passport at all times).
- Proficiency in spoken and written English is a MUST.
- Knowledge of ICH GCP and device regulatory requirements across geographies is required. Clinical Research certification is highly desirable (i.e. ACRP, SoCRA).
- College degree with a focus in health/science or other related field and/or other relevant field experience.
- Familiar with medical terminology.
- Advanced computer skills with proficiency in Microsoft Office Suite and Adobe required;
- Experience with trial Databases required
- Excellent organizational and leadership capabilities
- Ability to foster relationships with clinical sites and colleagues
- Ability to support several projects simultaneously, a flexible working style, and attention to detail are essential
- Able to work independently with excellent time management skills
- Excellent work ethic with desire to be a valuable contributing team member
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Clinical Research Manager - Dallas, United States - INSIGHTEC
Description
What you will be doing:Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery. Based on two decades of clinical experience and research and development, the company's Exablate Neuro platform focuses sound waves, guided by MRI, to provide tremor relief to patients with Essential Tremor and Tremor-dominant Parkinson's Disease.
Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions.
We are a global team united by a common vision to transform healthcare by making focused ultrasound a standard of care for patients. Our culture is built on Our Values of integrity, team, quality, innovation and patient care. We challenge and empower our people to be great at what they do and leverage our different ideas, skills, interests and cultural backgrounds to succeed.
After a recent investment round, Insightec is valued at more than $1B, bringing it to unicorn status. We are over 350 strong in Haifa and K. Ono in Israel, Miami, Dallas, Shanghai and Tokyo.
Do the most meaningful work of your career by joining us in our mission to make the impossible possible.
Insightec is an equal opportunity employer and is committed to a safe work environment free from discrimination, where employees are treated with dignity and respect. Insightec does not discriminate against any employee or applicant on the basis of race, color, religion, national or ethnic origin, sexual orientation, gender identity or expression, age, disability or other characteristics protected by law. We adhere to these principles in all aspects of employment including hiring.
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