Senior Level Clinical Trial Management (Contractor)

Reports To: Sr Director, Clin Ops

Department: Clin Ops

Location: SSF Office / Hybrid / Remote

 

ABOUT THE JOB

Reporting to the Sr Director, Clinical Operations, the Clinical Trial Management Contractor serves as the operational project lead for a global clinical trial in rare bleeding disorders.  The CTM Contractor is the primary operational contact for the assigned studies and leads the cross-functional study management team. This key role 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). The CTM Contractor 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 CTM Contractor demonstrates a strong drive to apply innovative approaches to accelerate drug development.

 

OUR CORE VALUES

The below core values drive all that we do here at Star.  We are looking for like-minded individuals that feel passionately about these same values to join our team.

  • Patients are our Center of Gravity: We partner with patients in unique ways, to uncover and address their unmet needs.
  • Propelled by Data, Guided by Intuition, Informed by Expertise: We boldly explore new diseases, novel biology, and smart ways of working with a sense of urgency.
  • Mission Ready Crew: With courage and agility, we opportunistically challenge conventional wisdom and foster an environment of respect and continuous growth.

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

 

EDUCATION, EXPERIENCE & QUALIFICATIONS

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

 

ABOUT STAR THERAPEUTICS

Star Therapeutics is a Phase 3 clinical stage biotechnology company that aims to discover and develop best-in-class antibody therapies to transform the lives of patients with serious diseases. Founded by former True North executives, Star has built a team with significant scientific, clinical, regulatory, and commercial experience that has a demonstrated track record of success and is backed by top-tier biotech investors.  We pride ourselves on our collective passion in bringing innovative therapies to the clinic and are committed to patients for whom no or limited treatment options exist.

Star is headquartered in South San Francisco, CA.  More information about Star can be found on our website at www.star-therapeutics.com.

We are an equal opportunity employer and value diversity at our company.  We do not discriminate on the basis of race, religion, color, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status.

We anticipate the hourly rate for the Clinical Trial Management Contractor position in our South San Francisco, CA office to range from $100 to $130 per hour and will depend on current market data and the candidate’s qualifications for the role, including education, experience and geographic location.  The compensation described above is subject to change and could be higher or lower than the range described based on several factors.

Qualified candidates should apply via our careers page at: https://star-therapeutics.com/our-careers/

NO PHONE CALLS or AGENCIES, please.

Note to External Recruiters: Submission of unsolicited resumes prior to an agreement set in place does not create any implied obligation.