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Feasibility Specialist

Pharmaceutical Product Development (PPD)

Multiple Locations

The Feasibility Specialist coordinates the gathering and consolidation of key information from investigators, in determining whether the patient population and investigator availability will support PPD in its ability to perform a given clinical trial.Responsibilities include:Coordinates the execution of non-billable and billable feasibility studiesPrepares formal feasibility reports (including narratives) for client presentationsAssists with identifying potential protocol enrollment risks as well as appropriate country and site selectionParticipates, as requested, in clinical intelligence gathering initiatives as alternatives to survey-driven feasibility assessmentsMaintains an accurate and comprehensive database of investigatorsAssists Clinical Management to expedite feasibility, site selection and study start-upParticipates in process improvement initiatives for Feasibility ServicesThe Feasibility Specialist coordinates the gathering and consolidation of key information from investigators, in determining whether the patient population and investigator availability will support PPD in its ability to perform a given clinical trial.Responsibilities include:Coordinates the execution of non-billable and billable feasibility studiesPrepares formal feasibility reports (including narratives) for client presentationsAssists with identifying potential protocol enrollment risks as well as appropriate country and site selectionParticipates, as requested, in clinical intelligence gathering initiatives as alternatives to survey-driven feasibility assessmentsMaintains an accurate and comprehensive database of investigatorsAssists Clinical Management to expedite feasibility, site selection and study start-upParticipates in process improvement initiatives for Feasibility Services Education and Experience:Bachelor's Degree (Business, Accounting, Finance, Life Science)3 years experience with analysis of data for trends to include; creating databases, tables and spreadsheets for analysis OR 1 year with proven competency and proficiency as a Feasibility Associate within PPD OR 1 year feasibility experience within another clinical research organizationOr equivalent combination of training, education and experience that provides the individual with the required knowledge, skills and abilities Knowledge, Skills and Abilities:Able to accurately target feasibility requirements to customer and business needsDemonstrates strong analytical skills and extensive experience with data and trend analysisAble to gather information from a variety of sources and analyze all data, providing management with comprehensive reportsAble to function as a team player and display a positive attitude and enthusiasm toward workAble to work independently and maintain progress with rapid changes in priorities, to work on multiple projects without loss of efficiency and move to new projects with relative ease providing deliverables on time with a high level of accuracyAbility to understand feasibility proposals and budgetsUnderstands Clinical Management processesPossesses expertise in software used by the department including MS Excel, MS Access, MS Word, MS Internet ExplorerAble to become proficient in CASCADEPossesses excellent written and oral communication skills and can exhibit with individuals of all levels of seniority, as well as across all applicable functional groups and locationsAble to effectively communicate with investigators, physicians, as well as all internal and external PPD clientsPossesses strong attention to detail and decision-making skillsPossesses excellent organizational skillsAble to deliver to business-critical timelinesAble to work on projects of a diverse and confidential natureWorking Conditions:Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international. Physical Demands:Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf.Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance. Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law. Education and Experience:Bachelor's Degree (Business, Accounting, Finance, Life Science)3 years experience with analysis of data for trends to include; creating databases, tables and spreadsheets for analysis OR 1 year with proven competency and proficiency as a Feasibility Associate within PPD OR 1 year feasibility experience within another clinical research organizationOr equivalent combination of training, education and experience that provides the individual with the required knowledge, skills and abilities Knowledge, Skills and Abilities:Able to accurately target feasibility requirements to customer and business needsDemonstrates strong analytical skills and extensive experience with data and trend analysisAble to gather information from a variety of sources and analyze all data, providing management with comprehensive reportsAble to function as a team player and display a positive attitude and enthusiasm toward workAble to work independently and maintain progress with rapid changes in priorities, to work on multiple projects without loss of efficiency and move to new projects with relative ease providing deliverables on time with a high level of accuracyAbility to understand feasibility proposals and budgetsUnderstands Clinical Management processesPossesses expertise in software used by the department including MS Excel, MS Access, MS Word, MS Internet ExplorerAble to become proficient in CASCADEPossesses excellent written and oral communication skills and can exhibit with individuals of all levels of seniority, as well as across all applicable functional groups and locationsAble to effectively communicate with investigators, physicians, as well as all internal and external PPD clientsPossesses strong attention to detail and decision-making skillsPossesses excellent organizational skillsAble to deliver to business-critical timelinesAble to work on projects of a diverse and confidential natureWorking Conditions:Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international. Physical Demands:Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf.Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance. Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

Job posted: 2021-04-01

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