[Remote] Clinical Research Leader, Neurovascular

Note: The job is a remote job and is open to candidates in USA. Johnson & Johnson is a leader in healthcare innovation, striving to improve health outcomes for humanity. They are seeking a Clinical Research Leader for their Neurovascular team, responsible for managing clinical trials and ensuring compliance with regulations and study milestones. The role involves collaborating with various stakeholders and overseeing the execution of clinical research projects.

Responsibilities

• Serves as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones, for J&J MedTech Neurovascular
• Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures
• May serve as the primary contact for clinical trial sites (e.g. site management)
• Develops clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, 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/ECs, contractors/vendors, and company personnel
• Interfaces, collaborates and oversees Clinical Research Associates (CRAs)
• Oversees and supports the development and execution of Investigator agreements and trial payments
• Is responsible for clinical data review to prepare data for statistical analyses and publications
• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need
• May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), contributing to cross-functional alignment
• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites
• Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated
• Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs)
• Supports planning, track and manage assigned project budgets to ensure adherence to business plans
• Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy
• May serve as the clinical representative on a New Product Development team
• May assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals; May assist with maintaining the overview to assure (study) commitments are timely 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-balance, accuracy in clinical claims and messaging
• Manages and/or mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal 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 all Federal, State, local and company regulations, policies and procedures
• Should develop 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 simple and more advanced situations but requires minimal guidance for complex situations
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed
• May act as Clinical Safety Coordinator: Coordination of all safety-related activities of clinical trials; Strategic planning and coordination of all new safety initiatives; Development of clinical study safety management plan (SMP) and study-specific safety flow in accordance with internal procedures and applicable safety regulations for clinical research; Cooperation with the necessary stakeholders (clinical study team, medical, clinical sites, regulatory, data management) on safety activities related to clinical studies and guarantee adherence to the SMP; Works with data management to ensure timely database notifications to relevant parties; Coordinates the collection of required information on safety events with the clinical study team; Cooperates with cross-functional teams (Research & Development, Complaint Handling, Quality/Regulatory, Medical Affairs, Medical Safety) to ensure safety and complaint reporting compliance for each clinical study; Coordinates review of clinical safety data with the clinical study team, Medical Affairs or Medical Safety team; Ownership of the study safety inbox and coordination of timely 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 board meetings and acts as point of contact for any questions; Ensures all 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 required
• BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred
• Previous experience in clinical research or equivalent is required
• Experience working well with cross-functional teams is required
• Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations
• Ability to provide scientifically strategic and scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projects
• Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations
• Strong presentation and technical writing skills
• Strong written and oral English communication skills
• Demonstrate competencies in the following area are required: Behave and lead in a professional and ethical manner
• Advanced project management skills with ability to handle multiple projects
• Ability to lead small study teams to deliver critical milestones, as may be assigned
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…)
• Clinical/medical background is a plus
• Medical device experience is highly preferred
• Clinical Data Management, Clinical Evaluations, Coaching, Critical Thinking, Data Savvy, Drug Discovery Development, Ethical and Participant Safety Considerations, Good Clinical Practice (GCP), Industry Analysis, Medicines and Device Development and Regulation, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Technologically Savvy

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

Company Overview