Responsible for implementation, planning, and execution of assigned clinical trial activities.
Serves as Clinical Trial Lead for one or more trials Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision
Provides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership)
Co-Leads study team meetings in partnership with Global Trial Manager; and collaborate with cross functional study team members
May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning)
Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
Plan and lead the implementation all study startup/conduct/close-out activities as applicable
Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)
Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)
Site-facing activities such as training and serving as primary contact for clinical questions
Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
Clinical data trend identification; provide trends and escalate questions to Medical Monitor
Develop clinical narrative plan; review clinical narratives
Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
Collaborate and serve as primary liaison between external partners for scientific advice

Requirements

Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred Neuroscience experience)
5+ years of experience in clinical science, clinical research, or equivalent (preferred Neuroscience experience)
Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
Excellent verbal, written, communication and interpersonal skills
Must be able to effectively communicate and collaborate across functions and job levels
Ability to assimilate technical information quickly
Strong sense of teamwork; ability to lead team activities
Proficient in Medical Terminology and medical writing skills
Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
Proficient critical thinking, problem solving, decision making skills
Understanding of functional and cross-functional relationships
Commitment to Quality
Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)
Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial activitiesclinical researchGCPICHstudy designdata reviewmedical writingdata monitoring committeesclinical operationsstatistics

Soft Skills

communication skillsinterpersonal skillsteamworkcritical thinkingproblem solvingdecision makingadaptabilityflexibilityleadershipcollaboration

Certifications

MDPhDPharm DMSRN