Sr. Clinical Project Manager

Therapeutics Inc.•San Diego, CA

6d•$110,000 - $145,000•Hybrid

About The Position

Founded in 1997 and built upon 27+ years of dermatology-specific experience, this company is the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego’s Top Workplaces, they pride themselves on 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. The Sr. Clinical Project Manager will provide project management and leadership to plan, prepare and execute high quality clinical trials. They 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.
In regards to Data Management: Perform SAP and DMP review, edit specifications review, and ensure query monitoring and resolution, review of data listings and clinical study report, as needed.