The Clinical Team Manager (CTM) isaccountable for achieving the final clinical deliverable within the time periodspecified in the contract with the Customer.

The CTM will be able to interpret data on project issues and make good businessdecisions with support from experienced team members or line management.Maintains profitability by ensuring clinical activity is conducted withincontract scope, through efficient management of the clinical team

Responsibilities may include:
Manages all clinical operational and quality aspects of allocated studies in compliance with ICH GCP.

Develops Clinical tools e.g. Monitoring Plan, Monitoring Guidelines in conjunction with Data Quality Plan.

Contributes to the development of the Master Action Plan (MAP)

Responsible for timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central).

May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, etc.

In conjunction with the project manager prepares, organizes and presents at Investigator Meetings.

Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies.

Responsible for the timely archiving of documents and study materials for the clinical department.

Monitors clinical activity timelines and metrics.

Provides regular status updates to PM for client reports.

Ensures regular project review, using PPD tracking & management tools, implementing appropriate recovery actions to ensure project timelines are met.

Reviews monitoring visit reports and ensures finalization is within contractual timeline.

Manages CRF collection and query resolution process

Monitors /co-monitors clinical trials as needed to assess performance and/or ensure contractual obligations are met.

Leads regular conference call meetings with monitors and other clinical team members.

May participate in bid defense meetings.

Education and Experience: Bachelor’s degree or licensed certified health care training Preferable to have Clinical Research Associate experienceSignificant clinical research experience (comparable to 3+ years) in all phases of study life cycle, including start up, interim and close out.Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.Valid Driver’s License. Knowledge, Skills and Abilities: Superior organizational skillsDemonstrated performance management abilitiesExtensive monitoring experienceExcellent judgment and decision making skillsEffective oral and written communication skillsExcellent interpersonal skills and problem solving abilityAbility to motivate and integrate teams and teach/mentor team membersAble to effectively prioritize workloadStrong attention to detailExpert knowledge of relevant regulations e.g. ICH/Good Clinical Practices, FDA guidelines, etc.Computer skillsAble to communicate in English, both orally and in writingAbility to travelWorking ConditionsWork is performed in an office/ laboratory and/or a clinical environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Physical DemandsAbility to work in an upright and /or stationary position 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, with frequent 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. 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 prohibitsemployment 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 otherstatus protected by federal, state, and/or local law.

Additional Information

Requisition ID: 155120
Additional Information

Requisition ID: 155120