- Manages study activities and reports study metric
- Formulate and institute Clinical Operations department role and implement into cross-functional activities.
- Assists in the preparation of training materials, SOPs and presentations related to the operation of the organization as a whole and trial specific conduct.
- Manages adherence to ICH/GCP/local regulations internally and across sites and vendors
- Travels as required to clinical sites, development partners, vendors, and industry events, as needed.
- Ensure that Clinical Operations practices and procedures meet clinical, quality and regulatory standards and client requirements and expectations.
- Develop, execute, and evaluate effectiveness of a Quality Management System.
- Responsible for effective cost management and monitoring to ensure progress toward cost/case goals.
- Assess capacity and resource allocation to ensure efficiency for continuous scaling of operations.
- Build and develop high performance Clinical Operations team and foster a cooperative work environment to meet company goals.
- Manage studies from operations perspective and prioritize clinical operations.
- Maintain awareness of developments in appropriate fields of clinical and scientific research.
- Manage hiring, training, professional development, mentoring, and performance evaluation.
Coordinate Clinical Operations function with all company departments.
- Work collaboratively with other members of the management team in the formulation and implementation of company policies, procedures and decisions.
- Participate as active member of cross functional committees.
- Ensure cross-functional support of Sales and Marketing initiatives designed to enhance and extend current product offering and exceed client service expectations.
*Initiate new patient recruitment channels and grow existing channels.
- Participate in business development, marketing activities, and proposal development by providing support from a provider service and clinical operations perspective.
- Represent company to potential clients, collaborators and partners and serve as spokesperson for issues related to clinical operations and services.
- Ensure human resource deployment to maximize throughput and quality and meet goals and timelines.
*Exploring local/community employee recruitment and retention programs
-Vocational schools
- 2 year Schools
- Penn State Branches
* Evaluate current bonus/commission structure and propose improvements as needed.
- Responsible for planning and compliance of physical facilities, and human, equipment and information technology resources to meet operational and regulatory needs of the clinical laboratory.
Direct PI/Sub-I Operations
- Lead and manage PI/Sub-I team to ensure that customer needs are met and delivery of services exceeds expectations.
- Oversee new PI/Sub-I implementation for provider service and education.
- Proactively manage at high level complex PI/Sub-I service issues, resolving issues quickly and efficiently.
- Ensure PI/Sub-Is are informed and current on all changes that impact them including company policies and industry changes and trends.
Reports to:
President- Kim Chapman with cross-departmental communication with managers regularly.
Medical, Dental, Vision
Supplemental Insurance - AFLAC
401K - 3% Company Profit Sharing
Free healthcare at Montgomery Medical
PTO
Holiday Pay
Bonus/Commission