Assoc. Study Manager, Study Manager, or Sr. Study Manager - CA in San Diego, CA at Apex Life Sciences

Date Posted: 3/14/2018

Job Snapshot

  • Employee Type:
  • Location:
    San Diego, CA
  • Job Type:
  • Experience:
    At least 5 year(s)
  • Date Posted:
  • Job ID:

Job Description

Job Description:

  • Responsible for working with one or several cross functional study teams (and/or sub-teams) to deliver clinical research studies on time, within budget and with good quality in compliance with Regulatory Authorities regulations/guidelines and SOPs/WPs.
  • Share best practices.
  • Contributing to process improvement initiatives. 

Main Responsibilities and Accountabilities: 

  • Provides operational support, direction and leadership to one or more clinical operations teams and/or subteams. 
  • Manages and supports activities related to the development and execution of cross-functional and third-party vendor activities and deliverables, including but not limited to, development and/or review of clinical data management conduct (e.g. CRFs, CRF guidelines, edit check specifications, database cleaning), relevant study plans (e.g., monitoring, quality, communication, etc.) protocol review for operational feasibility and consistency, tracking patient recruitment, and incentives. 
  • Participate in the development and management of the study timelines. 
  • Maintains oversight of and ensures consistency in the operational aspects of trial conduct and provides training across trials within a project, including involvement in daily management of CRO/Vendors/Contractors. 
  • Performs routine reviews of key data to identify trends, discrepancies, errors, etc. to ensure ongoing quality of conduct in accordance with the clinical development plan and applicable clinical trial protocol. 
  • Performs in-house review of site visit reports and tracking to ensure appropriate monitoring of trial conduct and satisfactory resolution of outstanding issues. 
  • Ensures consistency and quality of site monitoring visits, which may include conduct of periodic co-monitoring visits with CRAs and/or training and supervision of co-monitors. 
  • Ensures communication of relevant study information across study personnel, timely communication of urgent information to the appropriate Team members, and appropriate escalation of issues to study team leadership. 
  • Collaborates with other study Team members to ensure consistency and efficiencies across the study Team, and other in-house teams as assigned. 
  • Participates in maintaining tracking, management and reporting of clinical study budgets and in development of staffing/resourcing plans. 
  • Maintains and provides contemporaneous enrollment projections to support forecasting and management of clinical trial material and investigational product. 
  • Oversees the development and maintenance of study specific manuals and plans. 
  • Identifies and develops metrics and operational tracking tools to support the operations team and for reporting to senior management on clinical trial conduct. 
  • Develops, maintains and promotes positive, effective and collaborative working relationships with and among internal team members and as applicable, with external CRO and 3rd party vendor personnel and co-development partner study teams. 
  • Identifies areas of best practice and process improvements. 
  • Participates as requested in the development of SOPs and department level training. 
  • Participates in Clinical Operations initiatives and programs as assigned, including but not limited to development of SOPs, cross project initiatives, training, etc. 
  • Maintains awareness and training on current applicable regulations, rules, guidance and SOPs/Work Instructions. 
  • Ensures clinical trials are conducted in compliance with ICH/GCP, applicable regulations, rules and guidance, and applicable SOPs and Work Instructions. 
  • Other responsibilities as assigned.


  • Experience in supporting a Project Manager/Director leading a team or subteam in the operational aspects of managing phase 1-4 clinical studies/trials through all periods (initiation to closeout), collaborating with and managing vendors and/or CROs, and planning cross-functional operational activities within an organization, preferably working in a global environment.
  • Basic knowledge of project management related to operational aspects of a clinical study/trial including some experience supporting a Project Manager in the development of timelines, budgets and resource plans. Good knowledge of ICH GCP and US Code of Federal Regulations applicable to the conduct of clinical trials (i.e., 21 CFR Parts 11, 50, 54, 56, 312 and 314).
  • Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
  • Experience leading a small study or functional subteams with demonstrated ability to motivate and lead the team to deliver against commitments.
  • Well-developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.
  • Able to travel up to 25% including international travel.
  • Bachelor’s Degree or Graduate Degree in a field of science or nursing, preferably biology, chemistry, pharmacy, or other field related to human study.
  • At least 5 years clinical operations experience as a Clinical Research Associate (or equivalent) or higher level.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.