Assistant Design Phase Manager Jobs

Responsible for code reviews on behalf of management, in conjunction with the AOR.

Work with EPA, CORE, and Authority of Jurisdiction to manage issues, in conjunction with the Design Management team.

Will be responsible for the day-to-day management of one – three technicians and will perform some technical production.

Provide research regarding the project design, along with applicable code and regulatory requirements.

Facilitate the preparation of schematic, design development, and construction documents and manage construction administration activities for the project.

Manage all administrative tasks related to design for the project.

Manages relationships and establishes strong partnerships with CROs, vendors, investigators and other external partners.

BA/BS degree with at least 15 years biotech/pharmaceutical industry experience preferred in a Clinical Operations environment.

Expert level knowledge of early phase clinical studies, including vendors and other service providers to ensure optimal study execution.

Expert level knowledge of GCP, ICH, FDA and other regulations that govern the conduct of clinical trials.

Direct experience with the transition of assets into early phase research; develops innovative approaches to accelerate early phase study execution.

The U.S. Food and Drug Administration (FDA) approved RELYVRIO™ in September of 2022

Appropriate education and/or experience may be substituted on equivalent basis

Assist with remote and in-person monitoring visits

Other duties and responsibilities as assigned

Responsibilities will include but are not limited to:

Take vital signs, perform phlebotomy, and conduct ECGs on patients as described in clinical trial protocols

Work closely with at the Site to ensure timing of procedures is correct per protocol

Bachelor’s degree in Construction, Civil, or Architectural Engineering, Construction Management, Estimating, or equivalent field

Craft and manage project schedules and key milestones, hold team members accountable for reaching set milestones

Minimum two years of relevant experience

Shown positive and professional attitude, and strong customer service skills

Microsoft Office, Project, and pertinent web application skills at an intermediate level

Active listening skills and effective communication including openness to diverse input and feedback

Support Design Phase Manager and/or Construction Executive with management of design phase cost issues

Bachelor’s degree in Construction, Civil, Mechanical, Electrical or Architectural Engineering, Construction Management, Estimating, or equivalent field

Lead the Mortenson project team in achieving, schedule alignment, an integrated team experience, and construction readiness

Establish and manage project budget and scope expectations, budget trending logs, and any associated communications and resources

Create and manage project schedules and key achievements, hold team members accountable for reaching set achievements during the design phase

Foster an integrated team experience through communication and collaboration