Advanced Group

CSA Manager

3+ months agoManchester, United Kingdom

The CSA Manager is responsible for performance management of CSAs and Lead CRAs and ensuring the standardization, consistency and adherence of Site Management departmental responsibilities across the clinical studies. This includes all activities conducted by Lead/CSAs including feasibility, study-start-up, site management/monitoring activities; in addition to resource management, assurance of quality data and deliverables, and the development and growth of CSA staff.

Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.

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  • Acts as a subject matter expert for the Lead CSA and CSA roles
  • Provides leadership and mentorship for assigned Lead/CSA staff
  • Manages Lead/CSA performance and career development
  • Manages Lead/CSA team resourcing by working with the FSP Program Manager and Site Management Directors
  • Assists with study feasibility in assigned regions, as needed
  • Assists GSSU with study-start up activities, as needed in conjunction with assigned Lead/CSAs, acts as back-up.
  • Drives continuous development and training for Lead/CSA staff, including developing training material and training staff to applicable SOPs, regulations, requirements, and standards
  • Hosts one-on-one meetings and performs employee evaluations
  • Manages, maintains and oversees Site Management metrics
  • Performs Lead/CSA assessment visits and develops performance improvement plans as needed
  • Liaises with Global Clinical Development and applicable Study Execution Team (SET) members to ensure Lead/CSAs are fulfilling requirements and meeting project and client deliverables and timelines
  • Assists with Lead/CSA study team member transitions
  • Attends study team calls to support deliverables of a project, as needed
  • Interviews qualified candidates and ensures proper on-boarding to the Lead/CSAs
  • Manages training requirement completion by Leads/CSAs
  • A degree (BSc/MSc or equivalent) in life science, nursing, pharmacy, medical laboratory technology or other health/medical related area preferred. Other degrees and certificates considered if commensurate with related clinical research experience (e.g., diploma or associate RN, certified medical technologist)
  • A minimum of 3 years of direct CRA (Line) Management experience or managing clinical teams in Pharma or CRO environment
  • A minimum of 2+ years of additional on-site monitoring experience (both CRO and industry experience are acceptable)
  • Strong Leadership skills including excellent verbal and written communication, and presentation skills
  • Excellent interpersonal and organizational skills with attention to detail
  • Strong computer proficiency in MS Office including Outlook, Word, Excel, and PowerPoint; Global clinical trial experience preferred
  • Ability to work well in a team environment but also independently without significant oversight; Flexibility in work hours and ability to travel
  • Must be fluent in English and in the languages of the regions/territories that are assigned
Other Requirements: Must possess a current passport identity card, and valid driver's license

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Group in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Group's practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.

Job ID: A_RPO-14649