Clinical Study Manager
King of Prussia, PA
We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Study Manager in King of Prussia, Pennsylvania. The Clinical Study Manager assists with clinical operational planning activities and support of study execution. The CSM works closely with the Senior Clinical Study Manager to support one or more studies and may take on additional program responsibilities with oversight by Clinical Program Manager(s) (CPMs) or Therapeutic Area Clinical Operations Lead. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Clinical project management of a clinical study (studies)
- Help to create and drive study level timeline
- Assist with the collection of feasibility data to develop the enrollment
- Assist with study budget issues, as assigned
- Ensure regulatory compliance and GCP compliance
- Responsible for oversight of TMF with periodic audits
- Contribute to vendor selection and management including issue escalation
- Support with developing and managing study plans (including but not limited to Study Management Plan, Vendor Oversight Plan, Compliance Plan, TMF plan) and all associated documents
- May collaborate with CTS team to plan and coordinate IMP and non-IMP supplies
- May lend support to SET internal meetings
- Assist with development and execution of monitoring plan and monitoring oversight plan in collaboration with CPM and Site Management (COMs)
- Contribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and COMs
- Consult with COMs for strategic selection of countries and sites
- Help to ensure SET team and external partner(s) receive and document study specific training
- May report key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality
- Facilitate study close out activities through completion of Clinical Study Report
- Co-monitor as needed
- Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations
- Ensure complete and timely IMPACT updates
- Support regulatory submissions
- Review country and site ICF
- Support audits and inspections and resolution of findings
- Track contract execution and assist in resolution of site issues in partnership with Site
- Management and COMs
- Support IMP management
- Minimum 4 years’ relevant clinical research (or related) experience within the pharmaceutical industry
- A solid understanding of the drug development process, and specifically, each step within the clinical trial process
- Experience in supporting the execution of global clinical trials (pharmaceutical or research institute)
- Thorough knowledge of ICH guidelines and GCP and its applicability to all stages of the clinical development process
- Demonstrated proficiency in advanced MS Project
- Bachelor’s Degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health or medical related
- Other degrees and certifications considered if commensurate with related clinical research experience (e.g. diploma or associate degree RN, certified medical technologist).
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. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
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.