Sr. Manager, Project Management Planning

Therapeutics Inc.•San Diego, CA

1d•$100,000 - $140,000

About The Position

Founded in 1997 and built upon 25+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego’s Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients. You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important to the team so you take pride in delivering great work. You believe anything worth doing, is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently.

Requirements

Hold a Bachelor’s degree or higher and possess a at least 6 years' of project management experience supporting pharmaceutical clinical trials in a team environment.
Possess a strong foundation in clinical trial planning and execution, including the ability to: Define and manage study tasks, timelines, milestones, and deliverables
Lead and coordinate complex clinical trial designs across multiple concurrent studies
Assess, forecast, and manage overall clinical resource requirements
Demonstrate a thorough working knowledge of current Good Clinical Practices (GCPs) and a solid understanding of FDA and ICH regulatory guidelines.
Possess strong project leadership, cross-functional coordination, and risk management skills which are essential to this role.
Have excellent written and verbal communication skills with the ability to prioritize and manage multiple initiatives simultaneously.
Have high attention to detail.

Responsibilities

Create, update and maintain MS Project Plans for all clinical programs and trials.
Manage multiple clinical studies concurrently, ensuring alignment with program objectives.
Identify, assess, and proactively mitigate project risks and dependencies.
Oversee team project-to-plan performance for both internal resources and external vendors for all studies.
Provide senior management and clinical project managers guidance on project-to-plan performance for all key activities.
Manage/advise on resource allocation between studies competing for common resources (e.g. Data Management, Stats, Medical Writing, etc.) to assure timely completion of all trials.
Monitor study progress, enrollment, and operational metrics; escalating issues as needed.
Liaise with the Finance department to monitor project labor accruals versus budgeted amounts and task completion status.
Participate in weekly clinical team meetings.
Support Business Development with proposals and/or bid defense development as required.
Support Program Management.