Associate Manager, Onsite Clinical Operations

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)

Key Accountabilities:

• 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.

Skills:

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.

Education:

• 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.