Clinical Study Manager - Clinical Operations at Blueprint Medicines

Posted in Management 8 days ago.

Location: Cambridge, Massachusetts





Job Description:

Clinical Study Manager - Clinical Operations

Cambridge, MA

Requisition Number: CLO21-901

Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and hematologic disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research platform, including expertise in molecular targeting and world-class drug design capabilities, to rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we are delivering approved medicines directly to patients in the United States and Europe, and we are globally advancing multiple programs for genomically defined cancers, systemic mastocytosis, and cancer immunotherapy.

This position reports into the Associate Director of Clinical Operations (or above). This candidate will possess an understanding of Clinical Operations for successful execution of multiple clinical trials primarily in oncology and hematology indications in different phases of development.

Responsibilities:

Responsibilities of this position involve the day to day management and oversight of clinical trials in collaboration with a dynamic Clinical Development team.


  • Independent management of the operational aspects of Blueprint Medicines' clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites.

  • Identification and qualification of clinical trial sites and investigators alongside CRO including management of vital relationships.

  • Participation in decisions for site selection with Blueprint Medicines' team.

  • Supervise clinical trial execution, with a focus on site start up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and central labs

  • Management of clinical study budgets and execution timelines.

  • Leads team meetings for study management.

  • Facilitate investigator meetings, kick-off meetings, monitoring training, and CRO (or other vendor) meetings.

  • Develop clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials.

  • Attendance at site visits to ensure oversight of CRO monitors and effective collaboration with Investigators and site staff.

  • Review study reports and metrics to ensure timely collection of clinical data, samples, and lab results.

  • Collaboration on SOP development and promotion of standardized clinical business tools.

  • Development and review of study documents e.g. ICFs, study guidelines, operations manuals, training materials.

  • Development of action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.

  • Participation in the preparation of presentations of trial data for internal and external parties (management review, scientific meetings, and advisory boards).

Qualifications


  • Minimum Education Required: Bachelor's degree in a scientific subject area required. Advanced scientific degree is preferred.

  • The candidate should ideally have 4-6+ years in trial management with a sponsor company managing various phase clinical trials.

  • Experience in multiple phases of clinical trials and therapeutic areas, including oncology, would be helpful.

  • Experience in CRO, vendor and laboratory oversight is required.

  • Motivated self-starter who will flourish in a fast-paced company environment.

  • Creative problem solver with excellent communication and public speaking skills.

  • Strong interpersonal and organizational skills are needed, with a high degree of attention to detail. Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Project leader, Physician, etc.).

  • Ability to travel for up to 30% of time, both domestic and international, may be needed.

  • Detailed knowledge of GCP and current US FDA regulations, and knowledge of relevant global regulatory requirements a plus.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.