Career Opportunities

Project Manager

SUMMARY
Reports to: Director of Clinical Development

The successful candidate will be responsible for the planning, management and oversight of Phase II-IV clinical studies specifically acting as the liaison between Anaclim and the Sponsor to ensure that the project timelines, budget and other contractual items are met. 

FUNCTIONS

Project Management Activities include:

  • Responsible for the overall management of the clinical trial
  • Direct day to day responsibilities of the clinical trial
  • Serve as the main point of contact for sponsors
  • Resource and fiscal planning and management
  • Provide leadership to multiple cross functional areas
  • Negotiate and manage study budgets/grants
  • Develop Informed Consent Forms
  • TMF filing and maintenance
  • Vendor Management including central labs, IVRS, central IRBs and central ECGs
  • Functional management of clinical development staff such as CRAs and regulatory specialists
  • Manage scope changes
  • Interact with study sites and Investigators
  • Proactive contributor with strong problem solving skills
  • Solid understand of GCP/ICH guidelines
  • Strong written and oral communication skills
  • Proficient in Microsoft Office programs
  • Gantt charting experience such as Microsoft Project
  • Site identification/qualification
  • Chair project team meetings
  • Direct CRAs with regard to site visits and/or monitoring plan
  • Write the Project Plan and/or Study Operations Manual
  • Travel less than 25%

EDUCATION

  • BA/BS in biological sciences or related field, BSN, or relevant work experience

EXPERIENCE

  • A minimum of 1 year as a Project Manager in either the Pharmaceutical, Biotechnology or CRO industry is preferred
  • A minimum of 5 years in either the Pharmaceutical, Biotechnology or CRO industry is required

Apply now at hr@anaclim.com

Field Based CRA

SUMMARY
Reports to: Project Managers

Under minimal supervision, independently coordinate and perform activities in the evaluation, initiation, monitoring and closeout of Clinical Development clinical trials. 

FUNCTIONS

Monitoring Activities include:

  • Maintain knowledge of therapeutic area through familiarity with clinical and scientific literature and participation in professional activities
  • Maintain knowledge of the protocol, including all protocol specific requirements
  • Conducts evaluation, initiation, routine monitoring and close out visits
  • Case Report Form review
  • Ensures compliance to Sponsor SOPs and protocols
  • Ensures compliance to GCPs, ICH Guidelines and applicable regulations
  • Performs source document verification to ensure data integrity
  • Facilitates discrepancy management
  • Monitors adherence to randomization schedule and procedures
  • Reconciles investigational product
  • Returns the investigation product appropriately
  • Facilitates serious adverse event reporting and follow-up
  • Facilitates the collection of regulatory documentation
  • TMF filing and maintenance
  • Documents findings appropriately and timely in monitoring reports and follow up letters
  • Resolve CRF data queries with the investigative site
  • Communicates on a high level with the study team and investigational staff.  Does not hesitate to identify issues and present possible solutions 
  • Meets with the investigator to discuss study progress and any issues or problems
  • Resolution oriented

Site Management Activities include:

  • Monitoring functions as stated above
  • Input and maintain electronic site management systems
  • Identifies and evaluates potential investigational sites
  • Networks and develops region for future studies
  • Accountable for the information and recommendations in the site evaluation reports
  • Ensures appropriate, timely training of all site personnel
  • Manages multiple investigational sites for multiple protocols covering different therapeutic areas
  • Develops site specific management styles to increase level of success at each clinical site
  • Acts as an integral part of the study team and shares responsibility for the performance of the investigational site
  • Facilitates enrollment for selected sites (this is the same as the next bullet point)
  • Develops recruitment strategies with the investigator and site staff to meet enrollment goals
  • Makes recommendations to close out non-enrolling sites when enrollment strategies have been exhausted
  • Ensures adherence to study timelines
  • Motivates site staff to reach goals.  Develops successful, professional rapport with site staff
  • In conjunction with the study team, is empowered to facilitate change
  • Is aware of the needs of both the internal and external customers
  • Is an excellent and proactive communicator
  • Is the primary contact person for their assigned sites

EDUCATION

  • BA/BS in biological sciences or related field, BSN, or relevant work experience.

EXPERIENCE

  • A minimum of 2 years of Regional Monitoring experience within the pharmaceutical, biotechnology or CRO industry is required

Apply now at hr@anaclim.com

Available Positions


If you are interested in career opportunities with Anaclim please send a copy of you resume to hr@anaclim.com.