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Manager, Clinical Management (GPHS)
Pharmaceutical Product Development (PPD)
ZA-Johannesburg-Johannesburg ZA Woodlands D
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:
Manages, selects, trains, resources, coaches and performance management of respective staff, which may be inclusive of CRAs, PAs, RSMs and other clinical focused staff. Focuses on end results using metrics and key performance indicators to manage performance. May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across PPD. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. 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:
Managesstaff, providing coaching, mentorship and work direction
Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews, recruits and selects staff
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. Ensures timeliness and accuracy of timesheets and expense reports
Supports allocation activities per the local resourcing process. Supports activities of project managers and clinical team managers to optimize the operational running of projects. Escalates appropriately any issues which may impact project deliverables
Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate
Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required
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.
Participates in process improvement/development initiatives.
Ensures understanding and facilitation of the risk based monitoring approach.
May provide input into bids and contribute to the procurement of new business where required.
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:
Manages, selects, trains, resources, coaches and performance management of respective staff, which may be inclusive of CRAs, PAs, RSMs and other clinical focused staff. Focuses on end results using metrics and key performance indicators to manage performance. May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across PPD. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. 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:
Managesstaff, providing coaching, mentorship and work direction
Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews, recruits and selects staff
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. Ensures timeliness and accuracy of timesheets and expense reports
Supports allocation activities per the local resourcing process. Supports activities of project managers and clinical team managers to optimize the operational running of projects. Escalates appropriately any issues which may impact project deliverables
Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate
Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required
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.
Participates in process improvement/development initiatives.
Ensures understanding and facilitation of the risk based monitoring approach.
May provide input into bids and contribute to the procurement of new business where required.
Education and Experience:
Bachelor's Degree in a life science related field.
Significant clinical research experience (comparable to 5 years) including remote and clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out.
Line management experience appropriate to the size and complexity of the clinical management group in the designated country/region.
Valid Driver's License.
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: Excellent mentoring/leadership/supervisory skills
Advanced knowledge of clinical trials monitoring; Remote and on-site
Demonstrated understanding of or ability to learn PPD SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
Demonstrated ability to evaluate medical research data
Strong organizational and negotiation skills
Strong attention to detail
Effective written and oral communication skills
Good knowledge of English language and grammar
Competent use of computer to include data entry, archival and retrieval
Ability 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
Solid knowledge of medical/therapeutic areas and medical terminology
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.
Preference will be given to employees from the designated groups in line with the provisions of the Employment Act No.55 or 1998 (and any amendments thereto), PPD’s recruitment policy and the Employment Equity Plan’Education and Experience:
Bachelor's Degree in a life science related field.
Significant clinical research experience (comparable to 5 years) including remote and clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out.
Line management experience appropriate to the size and complexity of the clinical management group in the designated country/region.
Valid Driver's License.
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: Excellent mentoring/leadership/supervisory skills
Advanced knowledge of clinical trials monitoring; Remote and on-site
Demonstrated understanding of or ability to learn PPD SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
Demonstrated ability to evaluate medical research data
Strong organizational and negotiation skills
Strong attention to detail
Effective written and oral communication skills
Good knowledge of English language and grammar
Competent use of computer to include data entry, archival and retrieval
Ability 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
Solid knowledge of medical/therapeutic areas and medical terminology
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.
Preference will be given to employees from the designated groups in line with the provisions of the Employment Act No.55 or 1998 (and any amendments thereto), PPD’s recruitment policy and the Employment Equity Plan’
Job posted: 2020-07-22