- Partner with other Global Development Compliance functions, R&D QA, BPOs and functional leadership to ensure delivery of the end-to-end processes for incorporating Future Fit ways of working to enable the clinical trial delivery operating model (analyze, design, develop, implementation, adoption, change management etc.).
- Execution of the QMS SOP framework for clinical trial delivery, ensuring ongoing engagement of R&D QA, BPOs, stakeholders (internal and external) and functional leadership
- Work with R&D QA, functional leaders, BPOs and stakeholders (internal and external) to confirm business impact is well-understood and accountabilities are clearly defined
- Enable capabilities to maximize clinical trial delivery process definition and development efficiency, looking for opportunities for continuous improvement in our ways of working
- Facilitate the Business Process Owner (BPO) and Business System Owner (BSO) Network to ensure consistency and effective connections between business process and system process in clinical trial delivery
- Partner with GCP Functions to drive optimization activities and initiatives to ensure proper support (change management, training, adoption) is applied for successful implementation
- Provide support on QA QMS Initiatives
- Ensure process changes are incorporated as required by regulation or CAPAs
location: Telecommute
job type: Contract
salary: $97.64 - 195.30 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Experience with the pharmaceutical Industry, including research and development and clinical trials conduct
- Strong understanding of business process development and documentation best practices
- Visibly engage across the organization to ensure transformational impact
- Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
- Provide input to highly complex decisions that impact overall R&D
- Ability to seek diverse input from multiple stakeholders to drive innovative solutions
- Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution
qualifications:
Required:
- BS, MS or equivalent
- Minimum of 10+ years' experience in pharmaceutical, CRO, healthcare or related industry
- Minimum of 5+ years' experience with QMS and process development for clinical trial delivery
- Deep knowledge and/or experience within clinical trial delivery operations and clinical trial lifecycle
- Solid understanding of US CFR, GCP, ICH regulations and the clinical development process
- Experience in problem solving, negotiations and collaborative team building with peers and other stakeholders is required
- Demonstrated ability to positively influence outcomes, key project decisions, and strategic problem-solving
skills: SOP, ICH Regulations, Corrective and Preventive Actions (CAPA), Quality Management Systems (QMS)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
