We are currently searching for a skilled professional to join a well-known client’s team as a remote Senior Clinical Project Manager. The Senior Clinical Project Manager will ensure efficient study execution, including oversight of CROs, vendors and consultants that are involved with the clinical trial. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES:

• Ensure efficient study execution, including oversight of CROs, vendors and consultants that are involved with the clinical trial
• Responsible for oversight and project management of individual studies as assigned
• Offer advice related to study milestones and ensure accurate tracking and reporting of study metrics and timelines.
• Risk identification and mitigation efforts and advising senior leadership accordingly
• Offer input related to investigator recruitment/selection across project.
• Ensure study staff is appropriately trained on relevant guidelines, regulations and SOPs.
• Ensure trial adherence to ICH-GCP, Federal and local regulations and company specific SOPs.
• Participate in clinical operations’ initiatives and programs.
• Contribute to preparation and review of clinical documentation such as Investigator Brochures, clinical protocols, informed consents, annual updates to regulatory authorities, and trial status update
• Evaluate aggregate site metric/KPI data (as obtained from monitoring visit reports, data collection, etc.) as part of quality management review.
• Review the clinical components of regulatory submissions including, but not limited to safety, interim and final study reports.
• Participation in forecasting Investigational Medicinal Product and clinical trial supplies, interacting with appropriate functional areas as needed to resolve issues.
• Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews.
• Participate and respond to Quality Assurance audits and/or regulatory authority inspections.

EXPERIENCE

• Minimum of 7+ years’ experience in clinical research with at least 5 years’ experience in study management. Clinical Monitoring experience preferred.
• Experience in management of CROs, vendors and consultants.
• Documented training, knowledge and application of current FDA Regulations, ICH-GCP guidelines for clinical trials required.
• Experience developing trial plans including site monitoring, risk mitigation strategies, trial budgets and project budgets, site selection and clinical supplies management.
• Proficient written and verbal communication skills.
• Collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
• Therapeutic (oncology) or medical knowledge preferred.
• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.
• Position may require some travel.

EDUCATION

• Bachelor’s degree in health sciences or related field.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

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.

It is Advanced Group’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.