Manager Clinical Affairs

Discovery Life Sciences • Huntsville, AL

2d • $50,000 - $80,000 • Remote

About The Position

The Manager, Clinical Affairs contributes to our mission by overseeing our clinical sites to implement, expand and improve the processes and relationships of Discovery Life Sciences throughout its clinical site network. This individual will collaborate with other members of the Clinical Affairs team to monitor and execute all processes for Discovery Life Sciences to obtain maximum effective and efficient performance. Key contacts for this position include site personnel involved in the research trials - patients, administration, physicians, Clinical Research Coordinators (CRCs) and staff from operating rooms, lab, clinical areas, and pathology.

Requirements

• Bachelor’s degree, preferably in life sciences
• 3+ years of comparable clinical research or project management experience
• Knowledge of clinical research trials and previous leadership experience preferred
• CCRA, CCRP, or equivalent certification preferred
• Familiar with principles, concepts, and standard of care associated with clinical trial or research study design and execution
• Experience in a clinical research organization or oncology/infectious disease/autoimmune research.
• Strong attention to detail with excellent organizational skills and the ability to prioritize multiple tasks
• Must be able to tolerate the sight of body fluids including blood/blood products, stool, sputum, and tissue as well as tolerate unpleasant odors of various specimens and chemicals
• Ability to travel up to 20-30% of the time; Travel to clinical sites at a minimum of an annual basis.
• Preferred home base near a major airport

Nice To Haves

• previous leadership experience
• CCRA, CCRP, or equivalent certification
• Preferred home base near a major airport

Responsibilities

• Supervise all activities at assigned sites, which may include direct oversight and management of internal network Clinical Research Coordinators (CRC)
• Manage relationships at assigned sites and expand capabilities to incorporate new sites and procedures
• Maintain and grow collaborative relationships with all site personnel involved in DLS research
• Develop, coordinate and enforce systems, policies, procedures, and productivity standards
• Stay abreast of industry-accepted procedures
• Serve as liaison between DLS and sites to execute projects and maintain quality standards
• Partner with Quality and the site’s Regulatory on promptly reportable incidents (PRIs)
• Assist in the development and execution of site-specific performance plans
• Travel to clinical sites at a minimum of an annual basis
• Review and evaluate research requests to determine how sites can fulfill requests
• Evaluate gaps in sourcing capabilities and implement plan for addressing sourcing needs
• Maintain accurate data in Salesforce database and utilize communication tools
• Develop and lead site specific implementation plan for initiation (SIV) and closing of clinical sites
• Collect regulatory documentation, file properly, and ensure accuracy
• Update site specific files and trackers
• Manage, coordinate, and support clinical site monitoring activities according to the Site Monitoring Process for IMVs
• Schedule visits, obtain proper access (remote, if needed) and maintain all applicable correspondence
• Perform general monitoring functions per the Standard Operating Procedures (SOPs): review data according to monitoring guidelines, ensure all documentation is present, and compile findings and complete reports
• Resolve issues from previous visits, address protocol questions, and ensure outstanding documents are completed properly
• Resolve site and/or monitoring issues including appropriate retraining, issue escalation, and implementation of corrective actions (CAPA) to prevent recurrence, as needed
• Respect the privacy of the personal information of patients, co-workers, and all individuals with whom the Company interacts. Maintain and grow collaborative relationships with all DLS personnel

Benefits

• Competitive salary and benefits package options including medical, dental, vision, life, and disability which start on your first day of employment!
• 401(k) match program which starts on your first day of employment
• Time away from work (Generous vacation and paid time off, your paid parental leave, paid family leave, etc.).
• Professional development opportunities and reimbursement for relevant certifications.
• Collaborative and inclusive work environment that values diversity.
• Team-building activities and social events.
• Employee Referral Program and Colleague Recognition Program

What This Job Offers

• Job Type: Full-time
• Career Level: Manager