Associate Manager/Manager/Sr Manager Clinical Operations - Home Based South East

United States US

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Job Description

Job Description
PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.
Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.
As a manager at PPD, you will oversee daily line management responsibilities of an assigned team and serve as positive leadership and professional role model for respective staff.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Summarized Purpose
Oversees daily line management responsibilities of assigned team. Serves as positive leadership and professional role model for respective staff, which may include CRAs, RSMs, PAs (if applicable) and other clinical focused staff. Provides direct coaching and development support to operational teams. Ultimately responsible for effective resourcing, alignment, training and on-going professional and technical development for staff. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. Primary focus on line and performance management of team members assigned to any monitoring modality and/or environment (i.e. FSO, FSP, Government, etc.). Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to PPD SOPs and WPDs. Works in collaboration with the leadership team for resourcing needs.
Essential Functions
• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
• Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company. Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. Delivers training on Working PRactice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate.
• Supports allocation activities per the local resourcing process. Supports activities of study managers to optimize the operational running of projects. Escalates appropriately any issues which may impact project deliverables.
• Manages and reviews systems (e.g. CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.
• Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.
• Alerts management to quality issues, requests QA audits as appropriate, and supports direct reports and project team in providing audit responses as required.
• Participates in process improvement/development initiatives.
• Ensures understanding and facilitation of the risk based monitoring approach.
Job Qualification
Education And Experience
Bachelors Degree in a life science related field or equivalent and relevant formal academic/vocational qualification.
Significant clinical research experience (comparable to1 -5 years) including remote and clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out.
1+ year of leadership responsibility.
Valid Drivers License.
Valid Passport.In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills And Abilities
• Demonstrated effective mentoring/leadership/supervisory ability
• Excellent clinical trials monitoring skills; Remote and on-site
• Demonstrated ability to attain and maintain a good working knowledge of ICH GCP, applicable regulations and PPD/Client procedural documents for all non-clinical/clinical aspects of project implementation, execution and closeout
• RBM strategy knowledge and facilitation
• Ability to evaluate medical research data
• Effective organizational and negotiation skills
• Strong attention to detail
• Effective written and oral communication skills
• Good knowledge of English language and grammar
• Strong computer skills, proficient in MS Office, ability to obtain knowledge and master all clinical trial database systems. Leverage modern technology when applicable
• Availability to travel as needed
• Excellent team player with team building skills
• Excellent interpersonal and conflict resolution skills
• Ability to utilize problem-solving techniques applicable to constantly changing environment
• Proficient knowledge of medical/therapeutic areas and medical terminology
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Ability to provide support during start up activities if necessary
PPD Defining Principles
• We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you

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