POSITION TITLE: Senior Clinical Trial Manager, Clinical Operations
REPORTS TO:  Director, Clinical Operations (Oncology Program)
POSITION TYPE:  Full-time, exempt position

PharmaIN Corporation is a privately held clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, peptide-based therapies for liver diseases and in oncology.

We seek a highly motivated, results-oriented collaborative, agile leader with global clinical operations and drug development experience, who has a passion for operational excellence to fill our Senior Clinical Trial Manager (Sr. CTM) position in our oncology program and join our growing Clinical Operations group. This position may manage and mentor less experienced staff including entry level CTM(s), Clinical Research Associates (CRAs), and Clinical Trial Assistants (CTAs).

The Sr. CTM serves as the operational project lead for clinical trials, including study planning, budget and resource management, and oversight of Contract Research Organization(s) and project vendors. This person works closely with the Director, Clinical Operations (Oncology Program), and the VP, Clinical Development to lead a cross-functional study team to ensure the timely conduct of a high-quality global trial in accordance with the study protocol, Good Clinical Practice, Standard Operating Procedures, and applicable regulations.

KEY RESPONSIBILITIES:
The key deliverables for this role are the planning and execution of complex clinical trial(s) in accordance with corporate timelines and budgets.

• Independently manages and provides guidance and oversight for all components of clinical trials, from protocol development through clinical study report.
• Proactively manages and leads a cross-functional study team, including risk identification and mitigation planning.
• Recommends and implements innovative processes to improve and positively impact clinical trial management and deliverables.
• Manages CRO(s), including project management, site and study management, data management and statistics, medical writing efforts, etc.
• Develops and issues requests for proposals (RFP) from CROs and vendors to support assigned clinical trial(s).  Evaluates and compares proposals; recommends/rates vendors to meet trial needs.
• Coordinates other vendors involved in the trial such as central lab, specialty laboratories, eCOA, interactive response technology vendor (IRT), imaging vendors.
• Acts as a cross functional liaison, communicating trial status and issues, to ensure trial plan aligns with company goals. Escalates challenges appropriately to resolve issues related to study protocols or processes.
• Responsible for creating and maintaining timelines, including aligning study start-up, enrollment projections, study conduct, and close-out activities with study and project goals, and using these timelines to track and manage trial progress.
• Responsible for managing CRO and vendor budgets, including review of invoices for accuracy.
• Manages clinical site budgets and contracts for assigned clinical trials.
• Works with Medical Directors and CRO partners to identify and assess feasibility of potential clinical trial investigators and sites.
• May perform pre-study site visits, present at site initiation visits and develop trial-related training materials for study team members, external team members, and clinical staff.
• Responsible for oversight of site monitoring activities.
• Works closely with the study team to develop trial associated clinical forms, including electronic CRFs and user acceptance testing, SAE Forms, etc.
• Works with outsourced or in house data management groups to create and implement study-specific tools to ensure clean data, e.g., metrics reports, patient profiles, etc.
• Oversees the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participates in data reviews and review of statistical analysis plans.
• Responsible for the development of study plans, manuals and study specific documentation including informed consent forms.
• Assist or lead in the preparation of investigator brochures, study protocol(s), informed consent documents, clinical study reports, clinical sections of INDs, DSUR and IND annual reports, etc.
• Ensures trial team members are trained on protocol and study specific procedures.
• Responsible for oversight of study Trial Master File (TMF) for inspection readiness.
• Collaborates with Clinical Quality staff to develop a quality plan, including audit readiness assessments for assigned clinical trials.
• Participates in the recruitment and onboarding process for CTMs, CRAs, CTAs and other clinical operations team members. Provides oversight and/or mentorship for less experienced staff, CRAs and/or CTAs.
• May lead or contribute to development of departmental processes and initiatives; contributes to the development of standard operating procedures (SOPs), templates and forms and processes.

QUALIFICATIONS:
Must have strong knowledge of clinical drug development processes, clinical study design, study planning and management, and monitoring.

• Bachelor’s degree or equivalent in relevant field, nursing degree, or equivalent experience
• 4+ years of clinical trials experience, including CRA/field monitor in pharmaceutical, biotech or CRO setting; 2 + years with a sponsor organization a plus.
• Previous clinical site level trial management experience is a plus.
• Technical knowledge and experience in the planning, launching, monitoring, and closeout of Phase 1-3 clinical trials. Previous experience on multi-national clinical trials a plus (e.g., Europe, Canada, Asia Pacific regions).
• Strong knowledge of CFR, ICH, GCP and GDPR/data privacy requirements.
• Experience in complicated disease states including oncology, immune-oncology, hematology, or liver disease states.
• Experience operationalizing innovative, complex trial designs preferred (such as basket study, adaptive or continuous review trial designs).
• Strong understanding of the application of SOPs, and medical terminology.
• Ability to read and understand scientific literature.
• Experience with industry standard data management systems, trial master files, clinical trial management system platforms. Previous participation in the successful set-up and management of CROs and associated vendors, (e.g., IRT, central labs, data management, central imaging vendors, eCOA) a plus.
• Ability to review and analyze performance metrics through various systems for assigned areas of responsibility and vendors and drive actions toward improving results.
• Strong problem-solving skills with ability to anticipate issues and outcomes and respond strategically, proposing innovative “outside the box” solutions to challenges, including obtaining input from colleagues to derive solutions.
• Experience and competent at developing and delivering effective presentations in multidisciplinary settings.
• Excellent interpersonal and communications skills with the ability to work collaboratively as a member of a cross-functional team.
• Self-starter, comfortable and effective working in a hybrid work environment with department and cross-functional colleagues, and vendors based in different geographies.
• Strong attention to detail, and organizational and time management skills with ability to prioritize tasks to meet critical deadlines.
• Ability to prioritize urgent and important tasks and take necessary actions to inform/escalate to management and stakeholders as appropriate.
• Ability to utilize a wide range of computer applications and tools. Proficiency with MS Office Suite, Word, Excel, PowerPoint, SharePoint, TEAMs; Smartsheet and MS Project experience a plus.
• This position may require occasional work on weekends to attend scientific meetings or attendance at site/investigator study training meetings.
• This position requires up to 30% domestic travel and may include limited international travel. Has current or able to obtain passport for international travel.

ESSENTIAL TRAITS

• Willingness to “roll-up sleeves” and get work done to meet department and company goals and milestones.
• Leads by example and learns from mistakes
• Effectively pivots to meet changing demands in priorities
• Completes tasks on time to meet milestones
• Clearly communicates milestones, risks, mitigations, and essential feedback
• Comfortable communicating to stakeholders if timelines are at risk
• Values the input of colleagues
• Works efficiently without compromising quality
• Innovates and eliminates redundant, inefficient, and manual processes where feasible

LOCATION:
Our offices and labs are located in Bothell Washington, just north of Seattle. This position is a hybrid position with preference of location in greater Seattle area.

COMPENSATION:

This is a management-level position with a compensation range of $155,000 to $185,000 for a Senior Clinical Trial Manager.

At PharmaIN we engage equitable workplace strategies to ensure fair compensation. Actual compensation packages are based on a wide array of factors, including but not limited to skill set, experience, certifications, and location, in addition to internal equity, and alignment with current market data. We take care of our employees and offer generous benefit plans, flexible paid time off and competitive pay. We strive to make PharmaIN an environment where all employees can succeed.

The PharmaIN Team shares a passion for meaningful work and is committed to solving complex problems in liver diseases and in oncology to create new therapies for patients suffering with these diseases. We believe in innovative thinking, collaboration, flexibility, action, and healthy debate.

PharmaIN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. PharmaIN is also committed to compliance with all fair employment practices regarding citizenship and immigration status.