Clinical Trial Manager

In this new role, you will manage clinical trial(s) under the leadership of the VP, Clinical Operations clinical development team. You will collaboratively manage a global and early phase clinical trial though the development of the novel drug. You will bring early phase experience including IND submission, and have strong vendor management as well as project management skills You will develop an understanding of the needs of the teams with a collaborative outlook and the ability to manage workloads to meet project timelines.

Your role:

• You will manage clinical trials from start-up through close-out to ensure both internal and external deliverables are on time and on budget while facilitating collaboration across functional areas

• Work with the cross functional clinical team to coordinate the relevant and timely exchange of information/materials to support clinical trial delivery and execution

• Oversee the development of clinical trial project timelines and ensures communication and understanding of risks/challenges; establishes plans and monitors metrics; ensures that timelines are accurate and comprehensive

• Proactively manage clinical trial outsourced partners including identification of risk, to ensure trial deliverables and performance goals are met

• Day-to-day contact with CRO counterpart; daily review and identification of potential issues or problems with sites and communicates/escalates to clinical team as necessary

• Collaborate with CRO to keep clinical study database current and accurate

• Proactively manage and track project scope and change orders, for clinical trial operations

• Additional duties and responsibilities as required

What you bring:

• Bachelor's degree in life science or allied health field (e.g. nursing, medical or laboratory technology)

• At least 5 years' experience in trial operations, mostly within industry

• Will be skilled at attention to detail and with an eye for quality

• Excellent written and oral communication skills

• Strong working knowledge of GCP/ICH and other applicable regulations/guidelines

• Good organizational/prioritization skills with strong attention to detail

• Proficiency with MS Office: Outlook, Word, Excel, PowerPoint, MS Project, and SharePoint)

• Ability to work collaboratively with cross-functional teams and partner

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.