Senior Clinical Project Manager
POSITION OBJECTIVE: The Senior Clinical Project Manager will work in a matrix management environment and serves as the primary contact for interdepartmental and external study contacts. This role is responsible for managing all stages of a clinical study within GCP and ICH guidelines when direct management by the sponsor is required. The Senior Clinical Project Manager may also function as a liaison and provide support for sponsor managed studies in an international setting and may oversee CRO conduct and progress when outsourcing is required. The Senior Clinical Project Manager understands all aspects of project management and ensures that the study meets projected milestones within budget; may assist the Director of Clinical Operations in managing and implementing project management team meetings.
This position is a remote work position. See travel requirements listed below.
Essential Job Functions/Responsibilities
- Manages full scope of regional and global projects. Responsible for project team leadership
- Coordinate the standardization and maintenance of status reports and other information sources.
- Building and maintaining positive team and partner relationships
- Reviewing and identifying project study trends and proactively responding to respective team members
- Assuring projects assigned are run according to SOPs, FDA and GCP guidelines
- Work with cross-functional team and multiple business-partner communication for proactive study-wide problem-solving regarding study progress and trial issues.
- Participates in the development of risk mitigation strategies.
- Coordinate with project leadership to identify and notify appropriate parties of emerging out of scope activities.
- Participate in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operational processes.
- Provide input into the development of the CRF (data capture forms) design and completion instructions.
- Participates in the employee performance program by providing timely and accurate feedback regarding the performance of respective team members at least annually
- Collaborate with the TA(s) management staff & cross-functional management teams, in development of budgets and timelines for new studies.
- Performs ongoing vendor management (e.g. CROs, IVRS) including independent negotiation of vendors scope of work and budgets, performance management and issue resolution.
- Ensures accuracy and timeliness of vendor and site payments.
- Perform activities of Lead CRAs (Senior CRA and other monitoring staff) on a temporary basis as needed to move project deliverables and timelines forward.
- Provide expertise in managing sites and clinical monitoring activities utilizing advanced practices to assigned project teams. Provide advice and guidance to team members for assessment, resolution, and documentation of both routine and complex site and study issues.
- Review visit reports and escalate issues to medical and operational leaders.
- Ensures trial adherence to ICH/GCP/local regulations.
- Calculate clinical and non-clinical IMP requirements.
- With cross-function departments to ensure timely manufacture, packaging and IMP shipment to sites.
- Facilitate SAE medical review process.
- Assist medical and project leaders with safety reporting compliance.
- Coordinates data cleaning activities.
- Reviews query aging reports against timeline and works with functional team members or CRO to resolve queries according to plan.
- May review clinical data (listings and tables)
- Have an understanding of IND/NDA submission requirements.
- Assist with the review and revision of new and revised IND documents.
- Conduct quality control (QC) audits on annual and ad hoc IND updates.
- Serves as functional manager for contract study monitors
- Must be available for up to 30% national travel.
- Other responsibilities as may be assigned.
Required Education & Qualifications
- Bachelor of Science (applied science) or registered nursing degree (Masters preferred).
- At least six years of experience in Clinical and Project Management.
- Excellent Project Management skills.
- Direct and positive experience communicating with Clinical operations team and study sites.
- Excellent organizational skills and the ability to work effectively in a fast paced environment required.
- Must possess good analytical and researching skills.
- Must be proficient in Microsoft Word, Excel, Office and MS Project.
- Ability to educate, train and mentor team members.
- Must be available for up to 30% national travel.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.