Senior Clinical Project Manager/Clinical Project Manager, APAC
The Clinical Project Manager (CPM) is an expert on running various clinical activities such as clinical trials, limited releases and focus groups related to medical devices. The CPM will ensure that clinical activities are executed in accordance with applicable regulations and that the quality of clinical data generated from clinical trials or limited releases meets the regulatory requirements for approval. The CPM may also assist other departments to execute post marketing studies of approved products either to comply with regulatory approval conditions or to generate additional clinical information for marketing purposes.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Leads planning and communication with cross-functional teams to ensure proper execution and conduct of clinical activities
- Serves as a resource and lead expert for clinical affairs team
- Tracks and reports on the progress of clinical activities being run, including budgets and timelines
- Preparation, oversight and review of clinical affairs project- and program-related documents
- Participate in the preparation, review, updating and training of SOPs
- Works to improve and innovate ways to make processes and procedures more efficient and effective
- Lead in helping CRAs perform evaluations of potential investigational sites and investigators for participation in clinical activities
- Perform audits of investigational sites and investigators to ensure data integrity and protocol compliance
- Lead and provide guidance to CRAs in assist with negotiating and obtaining approval for investigator agreements
- Lead in helping CRAs with creation of monitoring plans for each clinical study
- Lead and provide guidance to CRAs for preparing IRB submission applications and obtain IRB approvals
- Assist in preparing Clinical Study Reports and annual safety reports, as required
- Lead CRAs to educate, train and support investigators and their staff prior to and during clinical trials of investigational devices (or limited releases of approved products)
- Assist with managing external vendors, CROs, etc
- Lead and guide CRAs in development of clinical protocols, case report forms, informed consent forms, investigator manuals, product instructions for use, and study training materials
- Lead the preparation of clinical documents for IRB submission
- Lead the preparation of applicable clinical trial descriptions on clinicaltrials.gov (or similar)
- Lead and guide CRAs in activities associated with clinical site start-up, monitoring, and collection of data through to study close out
- Work with CRAs and data management team to resolve data queries and to ensure data integrity and completeness
- Other duties as assigned, including study coverage as needed
- Provide support to audit processes and quality management system as required
- Travel may be required up to 50%
- Internal - Position interacts on a regular basis with members of Regulatory Affairs, Legal, R&D, Product Innovation, Marketing and with members of other departments as a representative to internal project teams as appropriate.
- External – Position interacts with investigational site personnel including investigators, their staff, clinical and administrative personnel, contract monitors, and data management. External interaction also includes Institutional Review Boards (IRBs), contractors, consultants, Contract Research Organizations (CROs), regulatory bodies and others.
- This individual will make decisions together with Clinical Affairs Management and will at times be required to make critical independent decisions when working with investigational sites and IRBs.
- The individual must possess highly effective interpersonal skills enabling them to lead a team through negotiation, coaching and mentoring, have a strong understanding of clinical studies including ICH-GCP guidelines, ISO 14155-2011 and other applicable regulatory requirements, and display flexibility and integrity.
- Bachelor of Science, or equivalent experience, required
- Masters of Science preferred
- 7-10 years of experience in clinical research in the medical device industry
- Minimum of 2 years experience as a senior clinical research associate
- Dental industry experience preferred
- Experience running clinical studies from a project management perspective required
- Well organized and detail-oriented person with strong written and verbal communication skills, be proficient in MS Office Suite, and have the ability to give presentations, multi-task and work effectively in a team or independently on assigned tasks.
PHYSICAL DEMANDS & WORK ENVIRONMENT
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- Physical Demands: While performing the duties of this job, employee is occasionally required to stand, walk, sit, and use hands to handle objects and tools; reach with hands and arms, talk and hear. Employee must occasionally lift and/or move light to moderate weight. Specific vision abilities required by the job include close vision and the ability to adjust focus. Person must be able to travel by airplane. Person must be able to stand and speak in front of a group. The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Work Environment: The noise level and temperature in the work environment is usually moderate. The work environment characteristics described are representative of those an employee encounters while performing the essential functions of this job.
WORK SCHEDULE / HOURS
- Regular business hours
We are an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We also respect your privacy. Our Applicant Privacy Policies can be found here: http://jobs.jobvite.com/align-tech/
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