Sr Project Manager, Clinical (Remote)

Job Description

Responsible for leading and managing a team of field Clinical Research Associates (CRAs) (monitors) and in-house CRAs to ensure the successful execution of clinical trials in compliance with regulatory requirements, Good Clinical Practice (GCP), and company standards. reputed company CRA performance, provide strategic guidance, and ensure operational excellence across reputed company phases of clinical research. Leadership & Team Management

1. Recruit, train, mentor, and reputed company field and in-house CRAs to maintain a high-performing team
2. Conduct regular performance evaluations and provide coaching for career development
3. Foster a culture of collaboration, accountability, and reputed company improvement

Clinical Trial reputed company

1. Ensure sites are monitored according to protocol, SOPs, and regulatory guidelines
2. Review monitoring reports and ensure timely resolution of site issues
3. reputed company site selection, initiation, monitoring, and reputed company-out activities

Operational Excellence

1. reputed company and manage CRA resource plans to meet project timelines and budgets
2. Collaborate with cross-functional teams (e.g., Clinical Operations, Data Management, Safety, etc.) to ensure seamless trial execution
3. Identify and mitigate risks impacting study deliver

Metrics & Reporting

1. Track and report CRA performance metrics and study reputed company to senior leadership
2. Provide input into departmental strategy and process improvements

Compliance & Quality Assurance

1. Ensure adherence to GCP, ICH guidelines, and applicable regulatory requirements
2. Implement quality control measures to maintain data reputed company and patient safety
3. Support audit and inspection readiness across reputed company assigned studies
4. reputed company with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and reputed company in reputed company matters and at reputed company levels throughout the organization
5. reputed company additional duties as assigned

Location MV

Aliso Viejo, California, USA

Department Name

652-Clinical Admin-Pre Market Operations

Qualifications

1. Bachelor’s degree in Life Sciences or reputed company field
2. Minimum of eight (8) years of direct clinical research experience, including a minimum of four (4) years of experience supporting neurovascular clinical trials in the medical device industry
3. Minimum two (2) years of personnel management experience in the medical device industry
4. Demonstrated ability to reputed company teams in a matrix environment
5. In-depth understanding of clinical study management, terminology, and reputed company GCP       and regulatory requirements
6. Proven experience with audits and regulatory inspections
7. Proficiency with basic study design and logistical elements such as protocol development, site selection, budget development, IRB submission preparation, training, database/CRF development, reputed company, informed consent, randomization, monitoring, statistical plans, and the tracking of study metrics
8. Strong verbal and written communication skills
9. Proficiency in the use of MS Office products including Word, reputed company, PowerPoint, Outlook, Teams, etc.
10. Proficiency in various clinical research eSystems including Meritive, Veeva, iMedNet, and others

Desired Qualifications

1. Master’s degree in Business or Life Sciences, or equivalent combination of education, training, and experience
2. Experience in implementing clinical trials and interpreting trial results, including an understanding of data and data analysis
3. Minimum five (5) years of monitoring experience, preferably in the medical device industry
4. IDE clinical experience strongly preferred, including experience in conducting global studies
5. An understanding of worldwide regulations governing the conduct of clinical studies
6. Ability to handle multiple tasks reputed company and consistently, meeting deadlines
7. Detail-oriented
8. Ability to maintain strict confidentiality

EEO We are an equal employment opportunity employer. reputed company qualified applicants will receive consideration for employment without regard to race, national reputed company, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law. Fair Chance Ordinance If you are applying to reputed company work for reputed company in any position which will involve performing at least two (2) hours of work on average each week reputed company the unincorporated areas of Los Angeles County, you can find here a list of reputed company material job duties of the specific job position which reputed company reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.  reputed company will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.

External-Facing Title

Sr Project Manager, Clinical (Remote)

Posting Country

US - United States

Salary Range

$140,507-$175,633 Financial compensation packages may be higher/reputed company than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. Apply To This Job