The Clinical Trial Manager (CTM)-Position located in Waltham, MA with 25% Travel

Scipher Medicine is a precision immunology company on a mission to match patients with their most effective therapy. We believe patients deserve simple answers to treatment options based on scientific data. We partner with leading payers, health care providers, and pharmaceutical companies to bring solutions to patients with autoimmune diseases. Using our proprietary network medicine platform, we commercialize tests revealing a person’s unique molecular disease signature and match it to the most effective therapy, ensuring optimal treatment from day one. The patient molecular data generated from our tests further supports the discovery and development of novel and more effective therapeutics. Scipher is headquartered near Boston, with operations in North Carolina’s Research Triangle Park and Irvine, California.

The Role

As the Clinical Trial Manager (CTM) you will be responsible for engagement with a variety of external and internal partners across the life cycle of multiple studies spanning strategic and functional contributions to drive study concept and design, feasibility assessments, study start-up, contract and budget oversight, data exchange and support of data analysis and interpretation. The position as defined by scope provides leadership, problem-solving, mentoring, and technical support to the Clinical Operations team to ensure compliance with the monitoring plan as well as ensures timeliness and quality of deliverables within the specified budget.

What will I do?

• Ensures appropriate oversight of Contract Research Organizations (CROs), clinical trial sites, and other external vendors, including assessment of performance against contractual obligations
• Responsible for site management oversight, clinical monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity
• Manage study activities including strategic engagement with key collaborators; development of protocol and Informed Consent Forms; completion of study feasibility assessments; study start-up activities including contract finalization, IRB submission and approval; finalization of study manuals and processes; and coordination and support of data integration and analysis
• Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities
• Reviews the study scope of work, budget and protocol content and ensures the clinical operations team is aware of the contractual obligations and parameters
• Uses prior clinical experience, operational data, metrics and reports to identify and mitigate risks to clinical trial management deliverables
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations
• Escalates to the Sr. Director of Clinical Operations any risks to clinical trial management deliverables (timeline, quality, and budget)
• Collaborates with other functional leaders such as Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews and provides feedback on other functional plans as they relate to clinical trial management activities.
• Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan
• Coordinates initial and ongoing training to the clinical operations team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, clinical plans and guidelines, data plans and timelines for the study.
• Maintain documentation of key study decisions and plans
• Ensure timely communication of decisions and deliverables
• Prepare and deliver study updates to Scipher Operations Leadership team
• Mentor and manage supporting staff within the Clinical Operations organization, as assigned
• Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CTA team members to sites for observation or conflict resolution.
• Reviews the content and quality of site monitoring documentation (site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Ensure these deliverables are provided according to company specifications, including delivery deadlines.
• Interacts with other functional departments related to clinical monitoring, and site management activities and deliverables. Provides status updates on the clinical deliverables and risks to leadership as per departmental or study agreements. Provides solutions for obstacles in protocol execution and site management.
• Oversees CTAs assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. Develop and support execution of corrective action plans at site and study level. Supports and completes activities to achieve data cut and lock deadlines.

Education and Qualifications

• Bachelor’s degree in scientific/health care field required
• Demonstrated ability to lead and align teams in the achievement of project milestones
• 3 plus years directly managing clinical trials within the Diagnostics, Biotech or Pharma industry
• Demonstrated expertise in site management and monitoring (clinical or central)
• Demonstrates understanding of clinical trial management financial principles and budget management
• Strong conflict resolution skills
• Experience in management of CROs, vendors and consultants
• Documented training, knowledge, and application of GCP and ICH guidelines in clinical trials
• Experience developing trial plans including site monitoring, risk mitigation strategies, trial budgets and program-level budgets, site selection and clinical supplies management
• Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills
• Ability to work in a fast-paced, dynamic environment with a great sense of autonomy and conviction
• Strong skills in collaboration, communication (both written and verbal), organization, attention to detail and multi-tasking
• Sound analytical and problem-solving skills; ability to act with a consistence sense of urgency
• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project, but with an ability to be adaptive and learn new programs as applicable in this role.
• Ability to work within a matrix team environment
• Ability to laugh at yourself

Travel-Expected travel: 25%

We at Scipher Medicine are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Scipher Medicine does not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.

To all recruitment agencies: Scipher Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, or Scipher Medicine employees. Scipher Medicine is not responsible for any fees related to unsolicited resumes.