Sr. Clinical Project Manager

Therapeutics Inc. • San Diego, CA

5d • Hybrid

About The Position

Founded in 1997 and built upon 27+ 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 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. The Primary Objective of the Sr. Clinical Project Manager is to provide project management and leadership to plan, prepare and execute high quality clinical trials. You will ensure that all clinical activities related to one or more clinical trials are managed effectively in support of regulatory submissions and subsequent approval of dermatological drugs and devices.

Requirements

• Bachelor’s-level degree in science/health related field or a combination of education and industry experience.
• 5 to 8 years of clinical research experience with at least 5 years of clinical trial project management experience.
• Thorough understanding of GCPs and FDA and ICH guidelines.
• Excellent written and oral communication skills with the ability to manage multiple priorities with high attention to detail.

Nice To Haves

• Master’s degree is preferred.
• Prior CRO experience preferred.

Responsibilities

• Responsible and accountable for multiple clinical trials and manage each project within defined timelines.
• Coordinate/execute of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review and approval of request for investigational test articles).
• Facilitate investigational site budget negotiations.
• Provide regular updates to TI staff, Sponsors, vendors and contract staff concerning status and progress of the trial.
• Facilitate protocol development as needed.
• Responsible for writing/approving clinical project deliverables such as scope definition documents, CRFs, source documents, monitoring plans, close-out plans.
• Responsible for ensuring the trial is “audit ready” at all times (project team training records, current regulatory documents, appropriate IRB approvals, monitoring tools required for the trial).
• Ensure that any audit observations are addressed appropriately and in a timely manner.
• Responsible for ensuring that project team members are compliant with TI SOPs and internal guidelines.
• Assist with training and supervising CRAs.
• Develop presentations, handouts and coordinate investigator meetings and make effective oral and written presentations.
• Perform oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported.
• Responsible for reviewing and approving all monitoring reports and correspondence with sites from CRAs.
• Perform SAP and DMP review, edit specifications review, and ensure query monitoring and resolution, review of data listings and clinical study report, as needed.

Benefits

• Voted one of San Diego’s Top Workplaces
• Company culture that values collaboration, diversity of background and thought, and dedicated talent
• Valued for your unique and important contributions
• Equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior