Sr. Director Clinical Development – Lilly Gene Therapy, Sensory
Eli Lilly and CompanySalary not specified
Full Time
Expert & Leadership (9+ years)
[Remote] Principal CRA/ Cell and Gene Therapy experience at Thermo Fisher Scientific
Brazil
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, Clinical ResearchIndustries
Requirements
- Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent relevant formal academic/vocational qualification
- Considerable clinical research monitoring experience (comparable to 5+ years) with a demonstrated high level of expertise in all aspects of clinical monitoring
- Valid driver's license where applicable
- Ability to work in office/laboratory/clinical/home office environments with exposure to electrical office equipment, biological fluids, potential infectious organisms, and fluctuating/extreme temperatures
- Frequent driving to site locations and travel (generally 60-80%, potentially more, including extended overnight stays)
- Ability to wear personal protective equipment (e.g., protective eyewear, garments, gloves)
- Ability to comply with specific sponsor/client/site requirements (e.g., disclosure of vaccination status or other personal information)
Responsibilities
- Monitors investigator sites, managing complex studies/functions or challenging sites using a risk-based monitoring approach
- Applies root cause analysis (RCA), critical thinking, and problem-solving to identify site process failures and implement corrective/preventive actions for compliance and risk reduction
- Ensures data accuracy through source data review (SDR), source data verification (SDV), and case report form (CRF) review via on-site and remote monitoring
- Assesses investigational product through physical inventory and records review
- Documents observations in reports and letters timely using approved business writing standards
- Escalates deficiencies and issues to clinical management expeditiously and follows through to resolution
- Maintains regular contact between monitoring visits with sites to confirm protocol adherence, issue resolution, and timely data recording
- Conducts monitoring tasks per the approved monitoring plan
- Participates in the investigator payment process
- Shares responsibility with project team on issues/findings resolution and investigates/follows up on findings
- Provides updates on potential trends across sites and strategies to the Clinical Team Manager (CTM)
- Supports Clinical Team Management/Clinical Manager of CRAs (CMCRA) in mentoring, training, and developing junior CRAs
- Assists in project-specific training for the clinical team
- Identifies areas for process improvements, shares solutions, and implements where appropriate
- Facilitates communication between sites, client, and PPD project team via written, oral, or electronic means
- Provides trial status tracking and progress update reports to the CTM as required
- Ensures study systems are updated per agreed processes
Skills
Risk-Based Monitoring
Root Cause Analysis
Source Data Review
Source Data Verification
CRF Review
Clinical Site Management
Investigational Product Accountability
Protocol Compliance
Mentoring
CRA Training
Cell and Gene Therapy
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees