Clinical Manager - Denmark

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Job Description

Clinical Manager – Denmark

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.

This position sits within Clinical Operations in Denmark, and you will be part of a dynamic management team of four. This is a permanent, full-time, office-based position in Denmark. There may be flexibility to offer some home-based working.

In this role, you will be responsible for managing, selecting, training staff, and performance management of respective staff, which may be inclusive of Clinical Research Associates, Clinical Trial Coordinators, Remote Site Monitors, and potentially employees from Start-Up Operations, e.g. Country Approval Specialists, and Contract Specialists. You will focus on end results using metrics and key performance indicators to manage performance, and you may lead or contribute to initiatives that enhance the department's performance or lead to process improvement across PPD. The role also collaborates with clinical operations senior management and executive staff on strategic planning and business development, and acts as point-of-escalation.

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 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.

Job Qualification

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.

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
• Excellent command of English and Danish 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

Management Role:
• Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.

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 have a flexible 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 a global 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.

*LI-SH1

Skriv i din ansøgning, at du fandt jobbet på ofir.dk


Clinical Manager - Denmark

Job Description

Clinical Manager – Denmark

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.

This position sits within Clinical Operations in Denmark, and you will be part of a dynamic management team of four. This is a permanent, full-time, office-based position in Denmark. There may be flexibility to offer some home-based working.

In this role, you will be responsible for managing, selecting, training staff, and performance management of respective staff, which may be inclusive of Clinical Research Associates, Clinical Trial Coordinators, Remote Site Monitors, and potentially employees from Start-Up Operations, e.g. Country Approval Specialists, and Contract Specialists. You will focus on end results using metrics and key performance indicators to manage performance, and you may lead or contribute to initiatives that enhance the department's performance or lead to process improvement across PPD. The role also collaborates with clinical operations senior management and executive staff on strategic planning and business development, and acts as point-of-escalation.

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 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.

Job Qualification

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.

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
• Excellent command of English and Danish 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

Management Role:
• Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.

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 have a flexible 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 a global 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.

*LI-SH1

Skriv i din ansøgning, at du fandt jobbet på ofir.dk


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