Develops, plans, managers and reports on laboratory projects and project progress or developments and ensures outcomes are aligned with client expectations.
Manages the delivery of clinical research studies from initiation to closeout. Ensures quality deliverables are presented on time and within budget; coordinates work streams and efforts of cross-functional project teams; identifies and evaluates potential project risks and develops mitigation plans; and serves as the primary point of contact with the project sponsor.
Manage the process of designing and launching clinical research studies; manage activities of the Sponsor/Clinical Research Organization (CRO); lead colleagues in the design and organization of project components during Start-Up; develop and maintain best practices within the organization.
location: Marietta, Georgia
job type: Permanent
salary: $100,000 - 110,000 per year
work hours: 9 to 5
- Develop the database design requirements which include configuration definition for full protocols, protocol amendments and sponsor study changes, developing and maintaining client design standards as applicable in accordance with the Clinical Protocol.
- Collaborate with colleagues during planning meetings regarding project timelines, and project-related issues focusing on capabilities within, but not limited to, Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management
- Responsible for providing updates to the Project Manager regarding action/issues logs, status sheets and timelines during the start-up phase, where applicable
- Communicate and coordinate set-up activities with clients and internal customers to ensure that all milestones are achieved
- Proactively manage changes in study related project scope, identify potential risks, and devise contingency plans
- As required, prepare and present study-specific materials and services at Investigator, Kick-off and Bid Defense meetings
- Participate in external and internal audits as required
- Provide day to day guidance to more junior staff assigned to project or within a specific program area; may act as a mentor as well as assist in the training and development of more junior staff
- Lead in the development of sponsor specific standards and program-specific set-up procedures
- Participate in improvement projects as defined by the relevant process improvement management team.
Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience along with 2 - 3 years prior experience.
skills: Project Management
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.