Site Manager/Director - Simply Biotech

Site Manager/ Director- Simply Biotech
Overview
Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.
Immediate opening for a Site Manager/ Director, in San Diego, CA who possesses:

• 5-10 years of experience in the clinical trial industry, working directly with subjects
• 2+ years of experience managing direct reports in a clinical setting
• Business development experience is a plus

Full : The Site Director is responsible for the profitable management of the clinical research business, consistent with company policies, principles, strategies, and objectives. Accountable for the overall coordination, organization, and efficient implementation of clinical trials management, operations, and regulatory compliance. Works closely with the Chief Medical Officer, Principal Investigators, Recruitment Team and Clinical Research Coordinators to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical and a regulatory perspective.
The Selected Candidate Will Be Responsible For

• Coordinates site visits and PI Meetings with the BD team and sponsoring organizations prior to study implementation and works with Clinical Research Staff to provide ongoing coordination of sponsor communications thereafter
• Ensures that all staff are adequately trained and adhere to Standard Operating Procedure and working guidelines
• Works closely with the VP of Quality to design and implement a Quality Assurance program for all research activities
• Coordinates approval of materials developed by site or sponsoring or managing organization by Institutional Review Boards (IRBs) and other outside regulatory organizations, as required
• Working closely with the Director of Operations, develops and implements business plans for achieving the strategic and tactical goals and objectives of the business
• Performing and/or overseeing all HR responsibilities for reporting staff including but not limited performance evaluations, corrective action plans, staff recognition, recruitment and onboarding of new employees, and management of staff schedules
• Oversees the preparation and submission of regulatory materials to sponsors and oversight organizations
• Participates in the weekly Business Development (BD) calls to review the site's pipeline for planning purposes and to provide feedback
• Maintain Standard Operating Procedures, working guidelines and associated training programs for the effective management of subject recruitment, appointment scheduling, informed consent, subject visits, source document preparation, timely Case Report Form and EDC completion and regulatory affairs
• Works with the BD team to complete feasibility, expedite protocol reviews and 'Go-No Go' decisions
• Ensures that studies are implemented in compliance with Good Clinical Practice (GCP) guidelines as promulgated by the Food and Drug Administration (FDA) and the International Conference on Harmonization (ICH)
• Providing access and/or resources for all employees to complete the training needed to perform job responsibilities
• Evaluates study protocols (e.g., with respect to enrollment/retention potential, site capacity and capabilities, and other determinants of success), with input from the Principal Investigator, Recruitment Manager and Clinical Research team, as necessary and contributes to decision as to which studies to pursue
• Develops and maintains complete training files for all staff as outlined in the company's Standard Operating Procedures
• Serving as supervisor and mentor to all direct reports as detailed by the organizational chart
• Coordinates approval of materials developed or modified at site by sponsoring or managing organization, as required

The Selected Candidate Will Also Possess

• Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner
• Certified in some aspect of research required
• Demonstrates the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy
• Understands regulatory requirements, as well as Good Clinical Practices (GCP), HIPAA and International Conference on Harmonization (ICH) guidelines.
• Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
• Excellent Computer Skills to include Word, Excel, PowerPoint, as well as proprietary applications unique to the clinical research industry (such as Study Manager)
• B.A. or B.S. required; advanced degree preferred
• Minimum of 3 years' experience in managing clinical trials.
• Excellent communication skills (interpersonal, written, verbal)
• Able to manage a staff of clinical professionals and create a productive, satisfying work environment
• Knowledgeable in medical terminology to communicate with physician offices, pharmacists and laboratory staff
• Ability to perform overnight business travel

Salary Range: $90k-120k/yr
For immediate and confidential consideration, please email your resume to [email protected] or call 858.427.3668
More information can be found at www.simplybiotech.com