Study Planning and Feasibility Specialist
King of Prussia, PA
We are currently searching for a skilled professional to join a well-known client’s team as a Study Planning & Feasibility Specialist, in King of Prussia, PA. The Study Planning & Feasibility Specialist, within Clinical Development Operations is responsible for developing and maintaining enrollment plans and providing overall support for feasibility and enrollment planning activities of Clinical studies. The position is responsible for supporting the clinical teams in order to drive rapid, accurate and robust assessments of program and feasibility, as well as the timing of key start-up and recruitment milestones. Focus will be on creating surveys, conducting searches, benchmarking assumptions, & accurate planning that are required for the delivery of clinical trials.
- Support processes for initiating study planning and feasibility activities, including internal and industry searches and working with manager to compile data driven study assumptions from protocol go through feasibility completion
- Support of the feasibility (study, country and site) process
- Maintain continuity across studies by distributing surveys and compiling feedback on results
- Involve relevant stakeholders in the feasibility process to ensure the all needs are considered ensuring effective scenario generation & planning; comparing CSLB’s past performance data and proposed scenarios from Industry or vendor data
- Drive accurate Enrollment Planning
- Support Clinical Operations early in the development cycle, providing initial enrollment timelines, potential Country Footprint and realistic study enrollment plans are developed and in place
- Liaise with the study teams to ensure any changes in current enrollment plans are updated in the enrollment plan and study teams receive timely enrollment status reports, including updated projections of enrollment completion based on actual performance
- Conduct due diligence checks for selected Investigators, sites or IRBs/ECs prior to PSV conduct and report ongoing as applicable
- Upholds and promotes the Company’s reputation externally by demonstrating high professional standards and integrity in all external contacts
- Maintains up to date knowledge of the Study Operations landscape, industry best practices and regulatory considerations
- Support study start up activities ad hoc including, but not limited to Confidentiality Agreements, document collection and filing into contract repository or the trial master file
- Domestic and international travel possible
- As a guide, a minimum of 5+ years’ relevant clinical research (or related) experience within the pharmaceutical industry
- A solid understanding of the drug development process; a thorough understanding of the processes associated with Feasibility, clinical study start-up and business operations
- Thorough knowledge of ICH GCP and its applicability to all stages of the clinical development process
- Well-developed strategic planning, observation and analytical operational execution
- Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines
- Ability to analyze with strong attention to details
- Strong organizational skills and ability to perform multiple tasks
- Ability and willingness to work collaboratively across multiple teams
- Effective use of IMS’ Study Optimizer system a plus
- Postgraduate qualifications
- Demonstrated proficiency in advanced MS Project
- Experience in conducting Global Clinical Trials (pharmaceutical or research institute)
- Demonstrated ability to lead teams and work in a fast-paced team environment. Possesses drive, energy and enthusiasm to deliver the program objectives
- Ability to understand all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report
- Possesses excellent planning, time management & coordination skills
- Maintains current medical/scientific/regulatory knowledge
- Excellent interpersonal and decision making skills. Demonstrates innovation
- Excellent written and oral communication skills
- Maintains computer literacy in appropriate software
- A minimum undergraduate degree in business, life science, pharmacy, 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.