This Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
DUTIES & RESPONSIBILITIES
Under minimal supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate procedures and guidelines, this position:
• 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 Operating Company;
• 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
• Manages and/or mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency;
• May act as Clinical Safety Coordinator (See ANNEX I – Clinical Safety Coordinator Duties and Responsibilities);
• May perform other duties assigned as needed;
• Is responsible for communicating business related issues or opportunities to next management level. 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.
EXPERIENCE AND EDUCATION
• 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.
• 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.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and
Functional and Technical Competencies:
• 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. Leadership required in alignment with Company Leadership Imperatives:
• Connect – Develop strong collaborative relationships with key internal and external stakeholders.
• Shape – Make recommendations for and actively participate and lead in departmental process improvement activities.
• Lead – Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.
• Deliver – Strive to ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance with SOPs and regulations.