Clinical Program Manager
Clinical Program Manager
Vyriad is an early clinical-stage company (Rochester, Minnesota) developing proprietary oncolytic virus therapies for the treatment of cancers with significant unmet needs. Revolutionizing cancer treatment is our long-term goal, requiring curiosity, perseverance, an openness to challenging convention and a commitment to excellence. We are united in our mission, and the goal to improve the quality of life of patients worldwide.
Position Overview and requirements
The Clinical Program Manager will support the Medical Director of Clinical Development in the planning and management of overall clinical operation execution for Vyriad’s clinical program. Responsibilities include but are not limited to the management of project timelines, regulatory documents, budgets, cross functional teams, investigational site selection and management, oversite of vendors, and meeting key project deliverables in compliance with SOPs, regulatory requirements and relevant ICH/GCP guidelines, and in alignment with department strategies and goals. Incumbent must have 5-7 years’ experience in clinical research and drug development with an emphasis on Phase I-II, must be able to demonstrate expertise in clinical project management and execution of clinical trials, from study start-up through study close-out, and final reporting of clinical development programs.
- Provides clinical operations support to the Medical Director to achieve all deliverables from clinical protocol to clinical study report
- Provide monthly updates to senior management team identifying risks, reviews metrics and key performance indicators per clinical project
- Drive cross functional team meetings and ensure open lines of communication are maintained across the project team members
- Responsible for managing and preparation of regulatory documents and communications with the relevant agencies
- Communicate with the designated CRO(s), clinical consultants, project team members and clinical study centers for study-related issues
- Manage day-to-day activities of ongoing multi-center clinical trials in partnership with largely outsourced teams
- Oversight of local laboratories to ensure quality and proper execution of sample management, and timely reporting of results as required to the study teams and or investigational sites as appropriate
- Oversee the preparation and implementation of clinical trials (including safety, data quality, drug compliance, trial timelines, budget, resources, patient eligibility, enrollment and retention)
- Manage and track clinical study supplies including IP inventory, clinical samples, laboratory kits, and other items as needed
- Identify, qualify and train appropriate clinical investigators, contract research organizations, central laboratories and/or external consultants required to meet project objectives
- Develop and manage study timelines and metrics to assure on-time study completion, and to assist in the management of project budgets within financial goals
- Oversees investigative sites' adherence to pertinent regulations through review of monitoring reports, and communications with investigators, study site personnel, and CRAs.
- Proactively identify and resolve clinical project issues and participate in process improvement initiatives as required, including risk-based quality management initiatives and SOP development
- Assist with contract management, invoicing, and vendor oversight/management as delegated
- Assist with the development of clinical protocols and amendments, informed consent forms, and case report forms
- Facilitate the development of clinical trial agreements and negotiation of investigator budgets
- Provide direction and oversight to the development of clinical documents (e.g., monitoring guidelines and plans, charters, etc.)
- Maintains awareness of industry trends and developments to help define the future strategic direction for clinical trials design and execution
- Prepare and distribute study binders, study management tools and other study related materials when necessary
- Assists in the planning and conduct of investigator meetings and ad boards, etc.
- Maintain routine reporting updates to Clinicaltrials.gov and other reporting boards as required
- Other duties as assigned.
- Bachelor's degree in biologic or related science or health-related field, or professional work experience equivalent required; an advanced degree is preferred
- 5-7 years’ experience in clinical research and drug development with a demonstrated expertise in clinical project management and execution of clinical trials from Phase I-IV from study start-up through study close-out and final reporting of clinical development programs
- Experience in Hematology and Oncology clinical practice, nursing degree a plus
- Comprehensive understanding of ICH E6(R2) GCP, FDA, and ICH guidelines required
- Candidates must be proficient in Microsoft Word, Excel, PowerPoint, and Project
- Strong English verbal and written communication skills
- Experience with project planning required
- Leadership, communication, management and organizational skills; conflict resolution and team building skills
- An ability to contribute creative, practical solutions to problems is needed
- Ability and willingness to travel as needed (< 15%).
Compensation and benefits
Salary is commensurate with experience and qualifications. A comprehensive benefits package including:
Employer paid Short- and Long-Term Disability
Simple IRA with an employer match
Work visa sponsorship is not available for this position.
How to apply
To apply please send a resume and cover letter to email@example.com. References will be requested, and background checks will be required prior to start of employment. Applications will be reviewed as received until the position is filled.
Please note this job description is not designed to cover or contain a comprehensive listing of 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.
Vyriad 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, national origin, genetics, disability, age, sexual orientation or veteran status.