Position Summary

Star Therapeutics is seeking to hire an experienced Senior Clinical Trial Manager to serve as the operational project lead for a global clinical trial in rare bleeding disorders.  The Sr CTM is the primary operational contact for the assigned studies and leads the cross-functional study management team. Provides operational leadership to ensure project milestones delivery on time, within budget, high quality, and in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions (WIs). Applies critical thinking skills for problem-solving and has the lateral and strategic thinking capacity to drive their assigned studies with effective communication across the organization. The Sr CTM demonstrates a strong drive to apply innovative approaches to accelerate drug development.

 

This position will report to the VP, Clinical Operations.

 

Primary Responsibilities

  • Responsible for all operational aspects and progress of clinical trial execution including ongoing tracking of all applicable performance metrics and quality indicators
  • Serves as an escalation point and resource for internal/external teams and investigational sites; partners with cross-functional groups to achieve deliverables
  • Oversees/facilitates country and site feasibility/selection processes
  • Develop/oversees subject recruitment/retention strategy and related initiatives
  • Provides operational and strategic input and/or approves study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference binders, Pharmacy Manual, Clinical Data Review Plan, etc.
  • Responsible for and participates in clinical service provider (vendor) selection process as a part of outsourcing activities. Provides oversight for all vendor operational activities (e.g., study management, monitoring, specifications development, UATs, issues escalations) including leading the vendor teams (CRO, etc.) through strong partnership/collaboration and inspiration
  • Responsible for the selection and study-specific training of CRO study staff, monitors, investigational sites, and vendors
  • Ensures that all aspects of GCP compliance and audit readiness are maintained throughout trial conduct
  • Creates, manages, measures, and reports timelines for milestone deliverables
  • Proactively manages/identifies potential study issues/risks and recommends/implements solutions with key internal/external stakeholders
  • Prepares metrics and updates for management, financial forecasting, and study budget management
  • Oversees internal team meetings, investigator meetings, and other trial-specific meetings
  • Participates in the development, review, and implementation of departmental SOPs, WIs, initiatives and processes
  • Strong understanding of the cost drivers and are accountable for the development, management, and reconciliation of overall study budget(s)
  • Collaborates in the development/management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines
  • Reviews/approves vendor invoices and manages accruals and payment processes for all clinical trial vendors including investigative sites
  • Performs other work-related duties as assigned
  • Has a strong drive to apply innovative approaches to drug development

 

Requirements

  • Ability to work onsite 2 days per week.
  • Demonstrated successful management of CROs and vendors.
  • Thorough knowledge of CFR and GCP/ICH requirements.
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
  • Experience in rare diseases preferred.
  • Excellent communication and organizational skills and the ability to work effectively in a fast-paced environment. Exceptional attention to detail.
  • Flexibility and willingness to step in and be a team player.
  • Strong problem-solving skills with the ability to focus on time-sensitive objectives.
  • Proficiency with MS Office products Word, Excel, PowerPoint, SharePoint.
  • Ability to travel domestically and internationally.

 

Education & Professional Experience

  • B.S. degree and a minimum of 6 years of clinical trial experience, including clinical
  • At least 5 years experience in clinical trial management, in pharmaceutical, or biotechnology
  • Experience in Phase I-III clinical trials, including global studies.


Salary Range

  • The hiring salary range for candidates residing in California for this position is $156,000 - $195,000 annually.  This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation geographic location, individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.  This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.

 

*Please note the preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive listing of all activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

 

Star Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  Star is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.