Project Manager, Us Clinical Operations - Remote, Usa

Overview

We are currently searching for a skilled professional to join a well-known client’s team as a Project Manager, US Clinical Operations. This remote role will implement and oversee all areas of clinical trial management within the U.S. Apply now to talk with one of our recruiters and learn more about this amazing career opportunity.

Responsibilities

• Prepare and present trial specific updates to management and cross functional teams
• Participate in the set-up and maintenance of study trackers (timelines and budget trackers), ensure proper oversight of the study progress, and review results with management
• Support the coordination and follow-up of all sponsored quality audits and any regulatory inspections
• Verify the TMF is being set-up, maintained, and archived in accordance with SOPs and ICH-GCP Guidelines
• Help with writing study documents such as protocol, informed consent, internal Standard Operating Procedures, etc.
• Facilitate excellent and appropriate communication with the clinical and executive team
• Review clinical trial-related invoices in a timely and accurate manner
• Develop appropriate study plans and other documents
• Collaborate with operations to ensure accurate management of all study-related supplies
• Oversee vendor performance, internal metrics, and communication of study status within the team
• Lead internal review process and external communication for clinical site contracts/budgets
• Drive process for evaluation and selection of CROs and investigational sites
• Recommend execution and risk mitigation alternatives to management
• Ensure that the clinical studies are conducted in accordance with the protocol, U.S. regulations, Good Clinical Practice Guidelines, internal Standard Operating Procedures, and applicable Quality Systems requirements
• Assist in the organization of and participate in investigational meetings/site training, as required
• Manage the clinical trial process (start-up through closeout) according to industry and corporate standards, with guidance from the Director, Clinical Operations
• Confirm that the progress and completion of the study is in line with Company goals
• Maintain strong working relationships with a diverse range of team members

Experience

• Read, write, and speak fluent English
• Excellent organizational and record keeping skills
• Excellent communication skills and understanding of the importance of open communication between all team members
• Understanding of respiratory clinical research particularly in neonatology; critical care/NICU experience desired
• Ability to participate in video conferences and respond promptly to emails/phone calls
• Minimum of 5 years of pharmaceutical clinical research experience working in various positions in the field of clinical trials, including CRA experience (either CRO and/or sponsor experience are acceptable) with focus on in-patient hospital trials required
• Strong critical thinking and problem-solving skills
• Ability to work independently without oversight, but also work well in a matrixed team environment
• Ability to efficiently organize/prioritize work and set deadlines
• Knowledge of the US regulations and guidelines governing clinical trials
• Advanced computer literacy
• Travel required
• Constructive and positive attitude

EDUCATION

• Minimum of Bachelor’s Degree in nursing, medical field, or other Life Sciences preferred
• GCP Certification

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.
• Credible. Detailed understanding of clinical methodologies and ability to provide sound analytical support, you quickly establish credibility as a reliable resource.
• 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.
• 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.

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. 506916