Mgr Clinical Mgmt (Commercial Team)

ClinicalManager (CRA Line Manager) – South Africa

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.  

Manages, selects, trains, resources, coaches and performance management of respective staff, whichmay be inclusive of CRAs,CTCs, RSMs and other clinical focused staff. Focuses on end results usingmetrics and key performance indicators to manage performance. May lead or contribute to initiativesthat enhance the department's performance or lead to process improvement across PPD. Collaborateswith clinical operations senior management and executive staff on strategic planning and businessdevelopment as required. Acts as point-of-escalation regarding performance concerns and training needsto ensure adherence to PPD SOPs and WPDs. Works in collaboration with the leadership team forresourcing needs.

Responsibilities include but are not limited to:

Manages staff, 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 andup-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 therisk basedmonitoring approach.

May provide input into bids and contribute to the procurement of new business where required. ClinicalManager (CRA Line Manager) – South Africa

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.  

Manages, selects, trains, resources, coaches and performance management of respective staff, whichmay be inclusive of CRAs,CTCs, RSMs and other clinical focused staff. Focuses on end results usingmetrics and key performance indicators to manage performance. May lead or contribute to initiativesthat enhance the department's performance or lead to process improvement across PPD. Collaborateswith clinical operations senior management and executive staff on strategic planning and businessdevelopment as required. Acts as point-of-escalation regarding performance concerns and training needsto ensure adherence to PPD SOPs and WPDs. Works in collaboration with the leadership team forresourcing needs.

Responsibilities include but are not limited to:

Manages staff, 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 andup-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 therisk basedmonitoring approach.

May provide input into bids and contribute to the procurement of new business where required. Qualifications:

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.

Fluency in English and Polish

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

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team.We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We haveaflexible working culture, where PPD truly value a work-life balance.We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.We are aglobal organisation but with a local feel.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - 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’ Qualifications:

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.

Fluency in English and Polish

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

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team.We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We haveaflexible working culture, where PPD truly value a work-life balance.We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.We are aglobal organisation but with a local feel.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - 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’