Parexel's Baltimore, MD Early Phase Clinical Unit is hiring an Associate Manager of Onsite Clinical Operations (scheduling/training). This position is responsible for all scheduling and training for the clinical staff. We are looking for someone that has great analytical and organization skills.
Please note: this position is 100% onsite (no remote work)
Drives a High-Performance Culture of continuous improvement, leadership, accountability, client focus, efficiency and profitability within Clinical Operations
Work closely with the Clinical Team Lead to make sure staffing requirements are met and if they are not find appropriate solutions
Demands First-Time-Quality by establishing clear expectations for staff performance, clear delineation of accountability for tasks and processes and consistent monitoring of work product
Authorizes hiring, transfers, performance reviews, compensation increases, and terminations in conjunction with unit management.
Interfaces with key department heads and direct reports to discuss status of current trials, as well as significant staffing hurdles, capacity issues, and staff utilization.
Collect and analyze metrics that reflect performance of the departments and utilize these data to guide decision making toward Unit objectives.
Maintains and participates in the fiscal objectives of the unit and recognizes cost reduction opportunities.
Possess thorough knowledge of all current study protocols.
Be available and supportive of Clinical Operations staff on dosing and heavy procedure days, to include assistance with performing study procedures, if necessary.
Develop and support training sessions on study protocols, specialized clinical/laboratory procedures, and ICH/GCP guidelines. Introduce new technologies and equipment for efficient operations.
Assist project teams in study preparation tasks such as input in drafting protocols/study specific manuals, ClinBase™ setup reviews and mock runs.
Participates in quality improvement initiatives.
Provide feedback on project feasibility, timelines, proposal review process and client negotiations.
Develop, implement, monitor, and support Standard Operating Procedures (SOPs), Training Curricula and work processes for Clinical Operations (inclusive of Transit Laboratory, Shipping, and Pharmacy) including global harmonization between PAREXEL EPCUs.
Provide support / consult on Quality Control, USP 797, GMP and GCP compliance, as needed.
Assist with audits (internal/external).
Establish working relationships with client representatives, promoting confidence and reliability around trial execution to delight the customer.
Other duties as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and is not to be considered as all-inclusive.
Ability to lead and motivate functional groups to be client focused, achieve Unit/project-specific objectives, and strive for continuous improvement
Thorough knowledge of applicable international and local guidelines and regulations (e.g. ISO 9001, USP 797, GCP, GLP, GMP).
Well-developed communication, managerial and other soft skills.
Highly organized with the ability to manage multiple tasks of competing priorities.
Self-motivated with a willingness to accept responsibility and challenges.
Computer skills; ability to use MS Word, Excel, Power Point and Outlook
Experience in dealing with confidential materials.
Ability to travel and work a flexible schedule according to business needs
Knowledge and Experience:
At least 3 years of clinical research or pharmaceutical industry experience
Preferred experience managing the staffing in a clinical or hospital setting
Management experience managing direct reports
Knowledge of FDA regulated drug development process, USP 797, GCP, GLP and GMP is preferred.
Bachelor’s degree, graduate of an accredited School of Nursing (BSN preferred), or Physician training BLS certification required, ACLS and CCRC preferred
This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.
- Quality Assurance
- Operations Management
- Supply Chain Management
- Operational Performance