Senior Clinical Trial Manager – REMOTE, USA in USA

Senior Clinical Trial Manager - REMOTE, USA - Advanced Clinical - USA - work from home job Company: Advanced Clinical Job description: OVERVIEW We are currently searching for a skilled professional to join a well-known client’s team as a Senior Clinical Trial Manager (CTM). This remote role will manage individual clinical trials and/or programs as part of the Clinical Trial Working Group. Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES • Manage external vendors and contract research organizations • Prepare study documents (Monitoring Manual, Study Operations Manual, Source Data Verification Plan, Laboratory Manual, etc.) • Organize and manage the design of study materials (CRFs, patient diaries, study participation cards, source documents, etc.) • Aid in protocol development and study report completion • Ensure adherence to GCPs, SOPs, and study protocols by overseeing monitoring activities at clinical study sites • Provide guidance/direction and manage CRAs • Track patient enrollment • Qualify, initiate, monitor, and perform closeout activities • Evaluate site reports • Assist in the coordination of data management activities and the support data query process • Coordinate study supplies • Negotiate contracts with vendors of clinical trial services • Review Informed Consent Forms, CRFs, and study-related materials • Plan and participate in investigator meetings • Confirm regulatory compliance of investigational sites using Client SOPs and FDA/ICH guidelines • Maintain current trial master file EXPERIENCE • Minimum of 5 years of relevant clinical trial management experience in the pharmaceutical industry required • Detailed knowledge of GCP, ICH guidelines, and FDA regulations required • Proficient in MS Office Word, Excel, PowerPoint, and Outlook required • Excellent oral/written communication skills • Strong organizational abilities • Travel required - up to 25% EDUCATION • Minimum of a Bachelor’s Degree required • Nursing Degree or Advanced Degree preferred To be a best-fit your strengths must include: • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. • Organized. You’re an efficient time manager and can handle the pressure of meeting multiple strict deadlines. • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. • Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges. • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives. • Credible. Detailed understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource. About Advanced Clinical Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience, and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions Regarding your application Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately. Equal Employment Opportunity It is Advanced Clinical’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available. Expected salary: Location: USA Job date: Sun, 10 Sep 2023 03:48:46 GMT Apply for the job now! Apply tot his job