Manager overseeing Project Management team in Clinical Research at Sanford Health. Collaborating with Clinical Research Managers and guiding strategic research initiatives.
About the role
- Clinical Research Leader managing clinical trials within the Neurovascular team at Johnson & Johnson. Leading projects ensuring compliance with regulations and fostering relationships across departments.
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.
- 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 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.
- 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.
- Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated.
Requirements
- 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.
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 period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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