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Director, Clinical Study Management

San Diego, CA, US
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COMPANY: PROSCIENTO, INC.

JOB TYPE: Permanent, FullTime

Summary: Provides leadership and management to the clinical study management and regulatory associates to ensure that all clinical trials are conducted in a timely, efficacious manner following Good Clinical Practices (GCP), ICH guidelines, and relevant FDA regulations to ensure a quality product. Performs duties in accordance with company’s values, policies, and procedures. Please note: The company is open to hiring a Director or Senior Director for this position. Essential Duties and Responsibilities include the following. Other duties may be assigned at the company’s sole discretion. Assists in the development and execution of project plans to ensure compliance with study protocols and delivery of high-quality study products. Directs and provides support for the CSM group to complete studies successfully within projected timelines. May function in the role of Clinical Study Manager. Provides oversight to ensure continuous quality improvement in the CSM department. Tracks appropriate metrics of staff performance and quality of study deliverables as directed. Assists in process improvement and revisions of SOPs(Standard Operating Procedures and WIs (Work Instructions). Additional Duties and Responsibilities for Director, Clinical Study Management All duties defined in level one above, and in addition : Meets with cross-functional teams to discuss feasibility of new projects and study timelines in order to successfully complete studies within projected timeframes. Reviews draft source documents as needed. Oversees completion of Case Report Forms (CRFs)/Electronic data capture, resolution of queries and communications of internal staff with monitors, sponsors, and other external parties. Ensures that data entry is delivered on time per contractual obligations. Conducts regular audits of study documentation. Actively pursues continuous quality improvement throughout department. Evaluates the project life cycle plans and processes to ensure each study manager is fully prepared and set to success at each project. Continuously generates metrics analytics for the department to ensure performance is at the highest quality in each role, and studies are delivered beyond expectation and in accordance to budgets. Manages the monthly and yearly departmental budget with strict adherence to compliance and creates necessary analytical material to accurately report departmental status to superiors and executives. Provides feedback and interacts with Budgeting and Contracting for budgetary performance in the three defined phases of a project: startup, active study, and closeout. Continuously looks for ways to make processes more efficient. Facilitates weekly staff meetings to ensure communication and guidance are provided to study management staff. Evaluates, coordinates, and provides guidance for the necessary department systems and software, and constantly monitors what the industry standard demand is to keep the department current and ahead of industry requirements. Establishes a constant education and development of subordinates to ensure each staff member is educated and trained at the highest industry standard norms and appropriate certifications are issued. Is an active member of the CRU leadership team, with the primary intent to enhance and improve the interdepartmental interaction and communication. Additional Duties and Responsibilities for Senior Director, Clinical Study Management All duties defined in levels one and two, and in addition : Oversees, coordinates, and provides leadership and strategic direction for clinical study management and its implementation in the CRU unit. Actively participates as a member of the company’s senior management team and communicates cross departmentally regarding strategy, issues, and process as it pertains to the clinical study management department. Oversees, coordinates, and provides senior leadership in the development and execution of project plans to ensure compliance with study protocols and delivery of high-quality study products. Ensures that all studies are conducted in compliance with GCP and study protocols, The company’s Standard Operating Procedures (SOPs) and Work Instructions (WIs), ICH guidelines, and relevant FDA regulations Meets regularly with the project pipeline team to review and discuss feasibility of new projects. Works with the clinical operations department to project study timelines. Directs and provides support for the CSM groups to complete studies successfully within projected timelines. Works with CRO Services to coordinate CRO studies occurring in the clinical research unit. Directs effective planning of CSM staff in providing for logistic requirements for new projects including consumables, necessary equipment, third-party vendors, budgets, and contracts. Actively directs continuous quality improvement in clinical study management. Participates as a CAPA board member. Plans and manages the CSM department’s infrastructure, team, and budget. Provides technical input and assistance to projects as circumstances arise including defining scope and changes in scope. Provides guidance to project management team in determining the feasibility of the solutions. Supervisory Responsibilities: Manages subordinate supervisors overseeing a team of employees in the study management department and is responsible for the overall direction, coordination, and evaluation of this department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include workforce planning, interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Director, Clinical Study Management Education and Experience: Bachelor’s degree or equivalent from four-year college or university; minimum 7 years previous clinical research experience including 5 years director level supervisory experience. Thorough knowledge and understanding of GCP’s, applicable FDA rules, regulations, and guidance documents governing conduct of human clinical trials. Senior Director, Clinical Study Management Education and Experience: Bachelor’s degree or equivalent from four-year college or university; minimum 10 years previous clinical research experience including 5 years director level supervisory experience. Has a thorough knowledge and understanding of GCP’s, applicable FDA rules, regulations, and guidance documents governing conduct of human clinical trials. Certificates and Licenses: Clinical Research Coordinator Certification or equivalent is strongly preferred at all levels. Language Ability: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations and clinical protocols. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, employees, and the general public. Math Ability: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Computer Skills: To perform this job successfully, an individual should have knowledge of the current MS Office Word and Excel. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is frequently required to walk. The employee is occasionally required to stand.
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