Senior Clinical Study Manager
King of Prussia, PA
Our client is looking for an experienced Senior Clinical Study Manager (Senior CSM) for a permanent salaried position in King of Prussia, Pennsylvania. If you are an experienced Senior CSM, this position could be the next great step in your career. You must have extensive experience overseeing and conducting clinical trial research studies and projects.
- The Senior CSM is responsible for clinical operational planning activities and leading study execution
- Works closely with the Senior Clinical Program Manager (CPM) on a program or leads one or more studies and may take on additional responsibilities as dictated by study size and complexity (with oversight by Senior CPM or Therapeutic Area Clinical Operations Lead)
- The Senior CSM participates in or may lead the study execution team (SET), oversees study level outsourcing, and takes preventive/corrective action(s) to address study level issues
- Create and drive study level timeline
- Develop overall feasibility concept and enrollment plan with input from COMs
- Develop and manage study budget
- Provide input on operational aspects of the protocol
- Ensure regulatory compliance and GCP compliance
- Responsible for oversight of TMF with periodic audits
- Responsible for/contribute to vendor selection and management including issue escalation
- Develop and manage Study Management plan and all associated documents (i.e. vendor oversight plan)
- Collaborate with CS&L team to plan and coordinate IMP and non-IMP supplies
- Plan, facilitate and lead SET internal meetings as well as act as the CSL lead for vendor meetings
- Ensure monitoring plan is developed and consistently executed in collaboration with COMs
- Contribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and COMs
- Assigns and documents study specific roles and responsibilities to internal and external team members
- Consult with COMs for strategic selection of countries and sites
- Facilitate and coordinate communications with external provider
- Ensure Clinical Operations team and external partner receive study specific training
- 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
- 6+ 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 overseeing global clinical trials (pharmaceutical or research institute)
- Budget forecasting and management
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
- Ability to work independently with some oversight in the support and/or management of clinical trial execution
- Minimum of Bachelor’s Degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
- 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.