Early Clinical Development Project Manager

Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.  No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role
The Early Clinical Project Manager (PM) leads the operational study team, manages key relationships with internal and external stakeholders and oversees all aspects of a given project to ensure successful execution. The PM develops and proactively manages study timeline and is responsible for the scope of work including third party vendor involvement. The PM adequately evaluates probability and impact of risk, develops and implements risk management plans to mitigate effect on project objectives and deliverables, and effectively navigates project budgets towards expected profitability.

What You'll Do Here

• Independently execute clinical trials from study award through archival

• Develop project-specific timelines and proactively manage the critical path to ensure on-time execution and delivery per scope of work Assess out of scope activities for potential change orders

• Act as the central point of contact for all internal and external stakeholder inquiries during execution of a project and maintain effective and efficient communication with all parties

• Ensure critical milestones are met using autonomy and interpersonal skills Manage and coordinate, along with the study team, any situation impacting study outcome and escalate as appropriate

• Plan and execute internal and external study team meetings Coordinate, review and approve study related documents including but not limited to protocols, informed consents, study manuals and plans, case report forms

• Create and maintain the Trial Master File, and ensure inspection readiness Support submissions to institutional review boards and regulatory agencies

• Work with Quality Assurance to ensure GCP and regulatory compliance is maintained Facilitate process of identification, selection, initiation, monitoring, and close out of appropriate investigational sites

• Review critical study data for accuracy and evaluation of protocol endpoints Provide effective oversight of third-party vendors

• Facilitate Lessons Learned meetings Participate in client visits, or host clients, as required

• Provide assistance to Business Development in promoting Altasciences' services.

What You'll Need to Succeed

• Bachelor or higher level degree in Pharmacy, Pharmacology, Medicine, Sciences. Equivalent fields and /or equivalent experience could be considered.

• Leadership

• Ability to work independently

• Organization

• Exceptional Communication

• Flexibility

• Client services approach (internal and external)

• Problem solving and risk mitigation

• Management skills

• Ability to travel for client visits, site visits and/or meetings (approx. 10%)

• Fluent English language skills required (both written and spoken)

• Microsoft Office (including MS Project)

What We Offer

The pay range estimated for this position is $80,000 - $100,000 yearly. Please note that hourly rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data.

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences’ Benefits Package Includes:

• Health/Dental/Vision Insurance Plans