Clinical Affairs Manager

Discovery Life Sciences is a trusted provider of quality biospecimens and laboratory services to hundreds of researchers across the U.S. and around the world. The Clinical Affairs Manager 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.

• Supervise all activities at assigned sites, which include coordination of all activities between Discovery Life Sciences and the Clinical Sites
• 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 Discovery research
• Develop, coordinate and enforce systems, policies, procedures, and productivity standards
• Stay abreast of industry-accepted procedures
• Serve as liaison between Discovery and sites to execute projects and maintain quality standards
• Partner with Quality and the site's Regulatory on promptly reportable incidents (PRIs) or non-conforming events
• Assist in the development and execution of site-specific performance plans
• Regularly visit clinical sites
• 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
• Maintain digital site binders and ensure documents update.
• Upload regulatory documents and track expiration dates
• 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
• 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

Education requirements:

• Bachelor's degree, preferably in life sciences (Nursing degree is a plus)

Qualification/Experience:

• 3-5 years of comparable or related medical laboratory and/or clinical research experience
• Knowledge of clinical research trials and previous managerial experience preferred
• CCRA, CCRP, or equivalent certification preferred
• Candidate should be 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
• Experience clinical study technologies, including electronic data capture (EDC) is a plus
• Highly developed organizational and analytical skills with the ability to multitask, prioritize time-sensitive activities and work both independently and as part of a team in a matrix environment
• Excellent presentation, communication and relationship-building skills
• Thrive in a challenging and results-oriented work environment
• Ability to build and nurture relationships with clinical site partners
• Ability to develop and implement strategic solutions to optimize and maximize site relationships
• Strong attention to detail with excellent organizational skills and the ability to prioritize multiple tasks
• Demonstrate ability to develop trust and maintain integrity with external clinical and scientific experts, institutions, peers, and others
• Proven ability to analyze problems, develop and implement strategic solutions to optimize and maximize systems
• Ability to work independently as well with interdisciplinary teams (internal and external)
• 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
• Strong proficiency with MS Suite
• Google Docs, and MediaLab experience is desirable but not required