Sr. Clinical Project Manager Therapeutics Inc. - 3.0 San Diego, CA Job Details Full-time $110,000 - $145,000 a year 1 day ago Qualifications Project reporting Incident reporting compliance Medical writing Project documentation Adverse event reporting Clinical incident reports Team leadership 5 years Presentations for conferences or internal meetings Vendor coordination Project communication management Master's degree Data quality management Clinical audit and monitoring Data integrity and documentation Schedule management ICH guidelines Clinical staff training Records management Bachelor's degree Team training Clinical program monitoring Adverse drug reaction monitoring Project management experience in healthcare Managing clinical research teams Vendor relationship management Leading team collaboration initiatives Clinical trial standard operating procedures Implementing research protocols Communication with regulatory authorities for clinical trials Full Job Description Who Are We? 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. Who Are You? 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. What is the Primary Objective of the Sr. Clinical Project Manager? You will 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.

Your Main Responsibilities and Duties Include:

You are responsible and accountable for multiple clinical trials and manage each project within defined timelines. You 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). You will facilitate investigational site budget negotiations. You will provide regular updates to TI staff, Sponsors, vendors and contract staff concerning status and progress of the trial. You will facilitate protocol development as needed. You are responsible for writing/approving clinical project deliverables such as scope definition documents, CRFs, source documents, monitoring tools, monitoring plans, close-out plans. You are 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). You ensure that any audit observations are addressed appropriately and in a timely manner. You are responsible for ensuring that project team members are compliant with TI SOPs and internal guidelines. You will assist with training and supervising CRAs. You will develop presentations, handouts and coordinate investigator meetings and make effective oral and written presentations. You will perform oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported. You are responsible for reviewing and approving all monitoring reports and correspondence with sites from CRAs. In regards to

Data Management:

You will perform SAP and DMP review, edit specifications review, and ensure query monitoring and resolution, review of data listings and clinical study report, as needed. To Succeed in this

Position:

You should have a Bachelor's-level degree in science/health related field or a combination of education and industry experience. A Master's degree is preferred. You should have 5 to 8 years of clinical research experience with at least 5 years of clinical trial project management experience. Prior CRO experience preferred. You should have a thorough understanding of GCPs and FDA and ICH guidelines. You should have excellent written and oral communication skills with the ability to manage multiple priorities with high attention to detail. The most likely base pay range for this position is $110,000 - $145,000 per year. Several factors, such as experience, location, tenure, skills, and particular business needs, will determine an individual's exact level of compensation. Consideration will be given to experience that exceeds the listed requirements.

•Candidates based in San Diego are preferred and would be required to be onsite per our company's hybrid schedule. Remote candidates will be considered but are required to come to the San Diego office upon hire, at year-end annual training and as needed. Will be discussed during interview process. We at Therapeutics, Inc. are committed to providing an environment of mutual respect where 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. If you are smart and good at what you do, we welcome you to apply!