Clinical Trial Line Manager
San Jose, CA | Direct Hire
Bayside Solutions is seeking a Clinical Trial Line Manager to be part of our Client’ s team in the South Bay. This is an opportunity to work with a local organization focused on the movement of new drugs or devices from conception to FDA approval.
The Clinical Trial Line Manager will be a crucial to ensuring the success of the Clinical project teams. Someone who has managed a team of CTAs or CRCs with working knowledge of clinical trial documentation, eTMF/TMF, and strong experience with study start-up, maintenance, and close-out would be ideal for this role. Individuals who are passionate about their long-term growth within an organization and have a proactive mindset would be a great fit for this team.
Our Client’ s culture is founded on core values that keep them committed to being a collaborative, innovative, honest, and adaptable place to work. They have built a family within the workplace, promote employees from within, provide opportunities for professional development, and encourage their employees to be active in their efforts to impact their surrounding communities. This has ultimately created an ideal work environment where you can have a fulfilling and balanced career in clinical research.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Clinical Trial Line Manager
- An opportunity to join an organization focused on the movement of new drugs or devices from conception to FDA approval.
- Work for a company that is local to the beautiful south bay area.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, vacation/PTO, and 401K.
Summary of Responsibilities:
- Management of Clinical Research Staff, more specifically Clinical Trial Assistants.
- Create an environment where Clinical Research staff can successfully achieve established standards of services to clients according to SOPs and contract stipulations.
- Coordinate with Project Managers and Client Managers in the identification and resourcing of consultants that meet business needs in a cost effective manner.
- Participate in recruitment of staff; review CVs, conduct telephone and face-to-face interviews and reference checks.
- Monitor performance of direct reports on a continuous basis, and perform periodic evaluations according to company policies and procedures. This may include solicitation of feedback from clients, client managers, and others, conducting performance discussions, and setting future goals.
- Identification of and communication to direct reports regarding performance issues, including advising of issue(s), and assessing additional training as needed.
- Conduct Monitoring Performance Assessments, and other training as needed.
- Interface with Human Resources regarding compensation, salary adjustments, promotions, disciplinary actions and other related tasks concerning employee evaluations, performance and sub-contractor performance.
- Work with Human Resources for development of performance plan, as required.
- Coordinate the training of staff in the areas of company’ s time and expense systems, travel policies and guidelines, overall management structure, professional conduct expectations regarding communication and deliverable expectations.
- May negotiate consultant sub-contract terms and conditions that meet company standards and practices.
- Participation in regular meetings regarding project staffing requirements, and other business activities.
- Maintenance of shared staff assignment spreadsheet.
- Communication of staff assignment changes and salary updates to HR personnel.
- Collaborate with Project Managers in establishing project-specific expectations for direct reports allocated to the projects, and assures they are understood by direct reports.
- Communication of any direct report performance issues to Director of Line Management.
- Review time and expenses reported by direct reports to ensure utilization of time as well as management of client' s resources are consistent, with expectations.
- Communicate regularly with Project Managers and Client Account Managers regarding performance of direct reports and assessment of project needs.
- Forward final signed reviews, contracts, essential employments documents, including documentation of training review, to corporate office for record keeping according to company policies.
- Ensure notes from phone interviews and reference checks are filed electronically on the server or forwarded to the corporate office for scanning to the server.
- Four or more years of successful CRA experience.
- Previous direct supervisory experience preferred.
- Detail oriented.
- Excellent organizational skills and strong problem solving skills.
- Familiarity with medical and pharmaceutical industry, and related terminology and practices.
- Willingness to travel as needed.
- Appropriate knowledge of FDA regulations and their practical implementation.
- Excellent interpersonal, communications, and management skills.
- Ability to work well under pressure, and meet multiple and sometimes competing deadlines.
- Ability to demonstrate cooperative behavior with colleagues and supervisors.
- Excellent organizational skills.
- Flexibility with changing priorities.
- Critical thinking and problem solving skills. Able to make supported decisions.
- Excellent communication and listening skills, including influencing and leading, delegation, and team development.
- Strong negotiation skills, conflict management, and adaptability.
- Computer proficiency in Microsoft Outlook, Word, Excel, Access, Project, and PowerPoint.