Senior Project Manager - Early Clinical Development

at  Altasciences

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 Senior Project Manager (Sr. PM) leads project teams, manages key relationships with internal and external stakeholders, supports logistics, and drives timelines and communication to ensure successful execution. The Sr. PM develops and proactively manages project timelines and is responsible for the scope of work including third party vendor involvement. The Sr. 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. May have a supervisory role to facilitate staff mentoring

What You’ll Do Here

• Independently execute complex projects 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
• 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
• Manage and coordinate, along with the project team, any situation impacting project outcomes and escalate as appropriate
• Coordinate, review and approve project related documents including but not limited to protocols, informed consents, study manuals and plans, case report forms
• Create and maintain Trial Master Files, and ensure inspection readiness
• Support submissions to institutional review boards and regulatory agencies
• Facilitate process of identification, selection, initiation, monitoring, and close out of appropriate investigational sites
• Contribute to protocol development regarding operational logistics
• Conduct budget reconciliations and provide project accruals

What You’ll Need to Succeed

• Bachelor or higher level degree preferred in Pharmacy, Pharmacology, Medicine, Sciences. Equivalent fields or experience may be considered.
• Minimum 6 years of clinical research experience required, including a minimum of 4 years of related Project Management experience.
• Quality Improvement

Understands the value of innovation and quality improvement; Improves processes and practices by identifying inefficiencies and redundancies; Collaborates with relevant personnel to improve the quality of products and service; Demonstrates efficiency and quality in one’s own work; Manages and sustains change initiatives.

• Stewardship

Uses available resources effectively and efficiently; Protects physical and intellectual property; Leverages resources for optimal outcomes; Actions consistent with the company policies

• Accountability

Accepts full responsibility for finding solutions to problems; Takes ownership in the mission of the company and understands role in employee success and satisfaction; Effectively addresses setbacks and ambiguity.

• Communication

Expresses thoughts clearly and respectfully both orally and in writing; Demonstrates effective listening skills; Clearly understands instructions and conveys information effectively; Fluent English language skills required (both written and spoken).

• Service

Provides helpful, courteous, accessible, responsive, and knowledgeable services and information; Addresses employee, management, and/or client questions and concerns in a timely and responsive manner; Demonstrates flexibility.

• Strategy

Ability to work independently; Monitors and re-evaluates decisions, priorities, and plans to achieve a vision; Identifies and focuses on the most significant priorities; Applies creative problem solving skills to develop solutions that eliminate unnecessary obstacles for employees, management, and/or clients

• Leadership

Applies skills and knowledge to achieve department and organizational goals; Self-aware and open to feedback; Makes work meaningful, and engaging for their team; Recognizes and develops talent; Delegates and provides good exposure to their team members

• Ability to travel for client visits, site visits and/or meetings (approx. 10%)
• Software: Microsoft Office, Client Relationship Management Systems, Electronic Case Report Forms, Electronic Trial Master Files, Timeline Management Software

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

What You’ll Do Here

• Independently execute complex projects 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
• 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
• Manage and coordinate, along with the project team, any situation impacting project outcomes and escalate as appropriate
• Coordinate, review and approve project related documents including but not limited to protocols, informed consents, study manuals and plans, case report forms
• Create and maintain Trial Master Files, and ensure inspection readiness
• Support submissions to institutional review boards and regulatory agencies
• Facilitate process of identification, selection, initiation, monitoring, and close out of appropriate investigational sites
• Contribute to protocol development regarding operational logistics
• Conduct budget reconciliations and provide project accrual