In this role you will be responsible for the day to day management of a clinical trial and will manage the study management team, vendors, clinical monitors and clinical trial sites. This position will also work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets. This position is responsible for ensuring achievement of own or others' project goals and objectives. This person may have line management responsibilities. This person is able and willing to perform all duties or functions of subordinates.
Job performance will involve a variety of activities including:
- Manages the operational aspects of clinical trials including turnaround time and reagent flow
- Participates in protocol, CRF development, Clinical Study Report preparation, PMA submission, as appropriate
- Prepares metrics and updates for management, as assigned
- Proactively identifies potential study issues/risks and recommends/implements solutions
- Participates in and facilitates CRO/vendor selection process for outsourced activities
- Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
- May work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
- Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
- Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
- Participates in the development, review and implementation of departmental SOPs and processes
- Recommends and implements innovative process ideas to impact clinical trials management
- Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
- Serves as a liaison and resource for investigational sites
- Set up and maintain internal clinical sample bank
- Responsible for gaining ethics approvals during trials
- Reviews site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
- Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
- Drive and determination
- Ability to work in a fast paced and dynamic environment
- Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
- Strong communication and presentation skills
- Driven to perform
- Self-directed: needs little explicit direction
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward.
- Leveling commensurate with number of years of experience.
- 5 to 6+ years of industry experience, with at least 3 years of direct clinical trial management experience at a sponsor or CRO
- Proven experience in managing CROS, specialty labs, outside vendors and international trials
- Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment
- Demonstrated knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
- Ability to travel up to 30% of time
- Proven ability to provide clinical expertise to a clinical development in a specified product area or project
- Bachelor degree or higher in a science or health related field required
ArcherDX, the NGS applications company, is developing and commercializing a novel approach to target enrichment chemistry. Next-generation sequencing technology based on Anchored Multiplexed PCR (AMP™) generates a highly enriched library of gene targets of interest for downstream genomic sequencing. Complemented by proprietary software and readily accessible reports, our technology enables dramatic enhancement in mutation detection speed as well as complex mutation identification and discovery.
Unless otherwise stated, all descriptions above are preferred but not required for our ideal candidate. Consideration will be given for comparable experience. ArcherDX is an Equal Opportunity Employer.
We offer competitive compensation and generous benefits programs. E-mail your résumé in confidence with salary requirements to firstname.lastname@example.org.
Principals only. Recruiters, please do not contact this job poster