Senior Manager, Study Planning and Feasibility

The Study Planning & Feasibility Manager within the Clinical Development; Strategic Business Operations group is responsible for Study Mobilization, Country and Site feasibility and Enrollment Planning activities in support of the Clinical studies.

This position will oversee the framework for ensuring study planning and feasibility standards and processes and KPI’s are met or exceeded. The position is responsible for supporting the clinical teams in order to drive rapid, accurate and robust assessments of program and protocol feasibility, as well as the timing of key start-up and recruitment milestones. Focus will be on data driven estimates, benchmarking assumptions, robust scenario development & accurate planning that are required for the delivery of clinical trials.

Reports to: Associate Director, Study Operations

• Direct reports: Study Planning and Feasibility Specialist. Management may include contract staff allocated either through a Staffing Agency, CRO or Functional Service Provider.

Main Responsibilities and Accountabilities:

• Ownership of the Study Mobilization process. Establish, implement and manage standards and processes for initiating study planning and feasibility activities, including build of data driven study assumptions from protocol go through feasibility completion.
• Full support of the feasibility process. Maintain continuity across studies by documenting changes from Early Estimates, Early Feasibility, Detailed Assumptions, Detailed Feasibility, to Recruitment & Start Up Planning.
• Partner with Clinical Operations management to implement processes and work practices that drive rapid, accurate and robust assessments of program and protocol feasibility at both the country and site level, as well as the timing of key recruitment milestones.
• Involve relevant stakeholders in the feasibility process to ensure the all needs are considered and realistic study enrollment plans are developed and in place.
• Review and Implement tools or systems to streamline the feasibility process with stakeholders.
• Own and drive accurate Enrollment Planning. Support Clinical Operations early in the development cycle, providing initial enrollment timelines, High Level Budget (as applicable), potential Country Footprint and develop key assumptions.
• Ensuring effective scenario generation & planning; comparing CSLB’s past performance data and proposed scenarios from Industry or vendor data.
• Ensure that study teams receive timely enrollment status reports, including updated projections of enrollment completion based on actual performance.
• Will oversee and maintain the use of Study Optimizer for planning and reporting enrolment projections.
• Liaise with study teams to facilitate knowledge and use of study start-up tools, processes and strategies to reduce start-up time and standardize procedures. Enables achievement of activation for trials; manages at a detailed level when required and resolves problems / escalates issues as appropriate.
• 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.
• Leads, manages and develops direct reports as applicable.

Position Qualifications and Experience Requirements:

• 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).

Essential Experience

• As a guide, a minimum of 6 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.


• Involvement in cross-functional, multicultural and international teams.


• Excellent ability to handle complex decisions.

Desired Attributes – The following are considered desirable:


• Postgraduate qualifications.


• Demonstrated proficiency in advanced MS Project.


• Experience in overseeing Global Clinical Trials (pharmaceutical or research institute).


Competencies:

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.


• Preferred experience of directly managing a team with direct accountability for performance/or with a direct customer relationship responsibility


• Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.


• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.


• Maintains current medical/scientific/regulatory knowledge.


• Ability to evaluate, judge and make recommendations regarding staff. Ability to assist in teaching/coaching and setting an example of ‘best practice’.


• Excellent interpersonal and decision making skills. Demonstrates innovation.


• Excellent written and oral communication skills.


• Maintains computer literacy in appropriate software.

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.