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PPD

Clinical Team Manager (FSP) Client Dedicated - Hematology/Oncology

PPD has an exciting opportunity for a Clinical Team Manager to join us exclusively supporting one of our strategic pharmaceutical partners in a home-based role. PPD works in collaboration with this partner; our CTM's are dedicated to this client's projects and sites, working within their teams, systems and processes on behalf of PPD.

The CTM is accountable for achieving the final clinical deliverable (usually clean data from eligible patients as specified in the study protocol) within the time period specified in the contract. You will serve as the operational point-of-contact and coordinate/manage indirectly all local clinical operations functions, other cross-functional experts, and external clinical investigational staff involved in the preparation and delivery of the studies.
  • Ensures achievement of the final clinical deliverable by monitoring clinical timelines and metrics, providing status updates to management, reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution.
  • Interprets data on project issues and makes good business decisions with support from experienced team members or line manager.
  • Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required.
  • Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central).
  • Collaborates with the PM to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
  • Responsible for the implementation and training of standardized clinical monitoring processes within the study. Responsible for the timely archiving of documents and study materials for the department.
  • May conduct Accompanied Field Visits (AFVs) as needed
  • Ensures that essential document quality meets the expectation of Regulatory Compliance Review. Reviews and follows up on all questions raised by the ethics committees.
  • May provide input into preparation of forecast estimates for clinical activities.
  • Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
We are looking for a candidate who thrives on project teams and is focused on delivering exemplary levels of customer service. We are seeking excellent communication and organizational skills and a self-motivated, flexible, and professional attitude.

In return PPD will offer you a positive and supportive working environment within one of the most engaged teams in the industry; who are truly recognized as the cornerstone of our success. We will provide you with meaningful work and the opportunity to acquire valuable personal and professional skills. Our vision is to be the global leader in our industry; based on consistent quality and execution, exceptional customer-aligned service and constant innovation.

Strongly preferred:

Study Management experience

Oncology experience

#GD

#LI-TH$

Job Qualification:

Education and Experience:
  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years clinical work experience, including field monitoring).
  • 2+ year study management experience in a CRO/Pharma strongly preferred
  • Strongly preferred: Hematology/Oncology and Study Management experience
Knowledge, Skills and Abilities:
  • Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
  • Good planning and organizational skills to enable effective prioritization of workload
  • Solid interpersonal and problem-solving skills to enable working in a multicultural matrix organization
  • Capable of working effectively in a changing environment with complex/ambiguous situations
  • Familiarity with the practices, processes, and requirements of clinical monitoring
  • Good judgment and decision-making skills
  • Effective oral and written communication skills, including English language proficiency
  • Capable of evaluating workload against project budget and adjusting resources accordingly
  • Sound financial acumen and knowledge of budgeting, forecasting and fiscal management
  • Strong attention to detail
  • Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
  • Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Working Conditions and Environment:
  • 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 Requirements:
  • 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.


Diversity Statement

PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

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