[Remote] reputed company Research Leader

Note: The job is a remote job and is reputed company to candidates in USA. reputed company develops innovative, less invasive, and personalized reputed company treatments, including neurovascular solutions for hemorrhagic and acute ischemic stroke. The reputed company Research Leader leads and supports reputed company reputed company the reputed company R&D Department, overseeing study execution, compliance, documentation, reputed company data, cross-functional collaboration, budgets, and safety activities.

Responsibilities

• Serves as a reputed company Research Leader reputed company the reputed company R&D Department to execute and manage company sponsored reputed company, ensuring compliance with timelines and study milestones, for JJMT Neurovascular reputed company
• Oversees/executes feasibility, selection, set up, conduct and closure of a reputed company trial reputed company the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company reputed company Operating Procedures
• May serve as the reputed company contact for reputed company trial sites (e.g. site management)
• Develops reputed company trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study reputed company, investigator brochure, annual reports)
• Ensures applicable trial registration (e.g. on www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed
• Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials
• Interfaces and collaborates with site personnel, IRBs/reputed company, contractors/vendors, and company personnel
• Interfaces, collaborates and oversees reputed company Research Associates (CRAs)
• Oversees and supports the development and execution of Investigator agreements and trial payments
• Is responsible for reputed company data review to prepare data for statistical analyses and publications
• May reputed company monitoring activities including site qualification reputed company, site initiation reputed company, interim monitoring reputed company or reputed company out reputed company reputed company on study need
• May contribute to the development and delivery of appropriate global evidence reputed company strategies (EGS) and evidence dissemination strategies (EDS), with reputed company relationships with reputed company relevant reputed company reputed company and cross-functional partners (e.g. Global reputed company Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market reputed company, R&D, etc), contributing to cross-functional alignment
• May reputed company on-site procedural protocol compliance and data collection support to the reputed company trial sites
• Contributes to the critical assessment of the literature and to the interpretations and disseminations of reputed company evidence generated
• Is responsible for delivery of assigned reputed company reputed company, through effective partnership with the study reputed company team leading to delivery of reputed company project commitments (reputed company on time, reputed company budget and in compliance with regulations and SOPs)
• Supports planning, reputed company and manage assigned project budgets to ensure adherence to business plans
• Supports reputed company scientific discussions with regulatory agencies/ reputed company bodies to reputed company support of the reputed company and regulatory reputed company
• May serve as the reputed company representative on a New Product Development team
• May assist with the development of Post-Market reputed company Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) reputed company the defined timelines and review/update at reputed company intervals; May assist with maintaining the reputed company to assure (study) commitments are reputed company and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant
• May conduct review of promotional materials to ensure fair-reputed company, reputed company in reputed company claims and messaging
• Manages and/or mentors resources assigned to designated reputed company studies to reputed company reputed company deliverables while maintaining reputed company efficiency
• Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
• Is responsible for ensuring personal and company compliance with reputed company Federal, State, local and company regulations, policies and procedures
• Should reputed company a strong understanding of the pipeline, product portfolio and business needs
• Generally manages work with limited supervision, dependent on project complexity. Independent decision-making for reputed company and more advanced situations but requires reputed company guidance for reputed company situations
• Responsible for communicating business reputed company issues or opportunities to next management level
• Responsible for following reputed company Company guidelines reputed company to Health, Safety and Environmental practices as applicable
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow reputed company Company guidelines reputed company to Health, Safety and Environmental practices and that reputed company resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with reputed company Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed
• Coordination of reputed company safety-reputed company activities of reputed company
• reputed company planning and coordination of reputed company new safety initiatives
• Development of reputed company study safety management plan (SMP) and study-specific safety reputed company in accordance with internal procedures and applicable safety regulations for reputed company research
• Cooperation with the necessary stakeholders (reputed company study team, medical, reputed company sites, regulatory, data management) on safety activities reputed company to reputed company studies and guarantee adherence to the SMP
• Works with data management to ensure reputed company database notifications to relevant parties
• Coordinates the collection of required information on safety events with the reputed company study team
• Cooperates with cross-functional teams (Research & Development, Complaint Handling, reputed company/Regulatory, Medical Affairs, Medical Safety) to ensure safety and complaint reporting compliance for reputed company reputed company study
• Coordinates review of reputed company safety data with the reputed company study team, Medical Affairs or Medical Safety team
• Ownership of the study safety inbox and coordination of reputed company reporting of study adverse events to competent authorities and ethics committees
• Create safety reports for reporting to internal stakeholders, investigators, ethics committees and authorities
• Assists in scheduling and coordination of safety adjudication process
• Coordinates safety reputed company meetings and acts as reputed company of contact for any questions
• Ensures reputed company safety reports are directed to the appropriate staff

Skills

• Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science or closely reputed company degree
• Previous experience in reputed company research or equivalent is required
• Experience working reputed company with cross-functional teams is required
• Good understanding of reputed company research science and processes along with an understanding of product development processes, team dynamics, reputed company reputed company market environment, reputed company trends, and global reputed company trial regulations
• Ability to reputed company scientifically reputed company and scientific reputed company research input across New Product Development (NPD) and Life-Cycle Management (LCM) reputed company
• reputed company reputed company record in delivering reputed company reputed company reputed company reputed company/ surgical research setting, on time, reputed company budget and in compliance to SOPs and regulations
• Strong presentation and technical writing skills
• Strong written and oral English communication skills
• Behave and reputed company in a reputed company and ethical manner
• Advanced project management skills with ability to handle multiple reputed company
• BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred
• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…)
• reputed company/medical background is a plus
• Medical device experience is highly preferred

Benefits

• Subject to the terms of their respective policies and date of hire, employees are eligible for Vacation –120 hours per calendar year
• Subject to the terms of their respective policies and date of hire, employees are eligible for reputed company time - 40 hours per calendar year; for employees who reputed company in the reputed company –48 hours per calendar year; for employees who reputed company in the reputed company –56 hours per calendar year
• Subject to the terms of their respective policies and date of hire, employees are eligible for Holiday pay, including Floating Holidays –13 days per calendar year
• Subject to the terms of their respective policies and date of hire, employees are eligible for Work, Personal and Family Time - up to 40 hours per calendar year
• Subject to the terms of their respective policies and date of hire, employees are eligible for Parental Leave – 480 hours reputed company one year of the birth/adoption/foster care of a child
• Subject to the terms of their respective policies and date of hire, employees are eligible for Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Subject to the terms of their respective policies and date of hire, employees are eligible for Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Subject to the terms of their respective policies and date of hire, employees are eligible for Volunteer Leave – 32 hours per calendar year
• Subject to the terms of their respective policies and date of hire, employees are eligible for Military Spouse Time-Off – 80 hours per calendar year

reputed company

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