Associate Manager Clinical Operations/Manager Clinical Operations/Senior Manager Clinical Operations - Home Based in DE, FL, GA, IL, IN, MI, NC, NJ, NY, OH, PA, RI, VA

Pharmaceutical Product Development (PPD)

Multiple Locations


Submission for the position: Associate Manager Clinical Operations/Manager Clinical Operations/Senior Manager Clinical Operations - Home Based in DE, FL, GA, IL, IN, MI, NC, NJ, NY, OH, PA, RI, VA - (Job Number: 171324)Associate Manager Clinical Operations/Manager Clinical Operations/Senior Manager Clinical Operations - Home Based in DE, FL, GA, IL, IN, MI, NC, NJ, NY, OH, PA, RI, VAAssociate Manager Clinical Operations/Manager Clinical Operations/Senior Manager Clinical Operations - Home Based in DE, FL, GA, IL, IN, MI, NC, NJ, NY, OH, PA, RI, VAPPD’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. 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:

Managesstaff, 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.

#LI-JN1

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. 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:

Managesstaff, 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.

#LI-JN1

Education and Experience:

Bachelor'sDegree in a life science related field or equivalent and relevant formal academic/vocational qualification.

Significant clinical research experience (comparable to 1 - 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 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:

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

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Ableto communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to w ork upright and stationary for typical working hours.

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.

This role requires independent travel up to 40%, inclusive of traveling in automobiles, airplanes, and trains.

PPD Defining Principles:

- 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.Education and Experience:

Bachelor'sDegree in a life science related field or equivalent and relevant formal academic/vocational qualification.

Significant clinical research experience (comparable to 1 - 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 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:

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

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Ableto communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to w ork upright and stationary for typical working hours.

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.

This role requires independent travel up to 40%, inclusive of traveling in automobiles, airplanes, and trains.

PPD Defining Principles:

- 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.US-New Jersey, US-Virginia, US-Georgia, US-Illinois, US-Michigan, US-Ohio, US-New York, US-Florida, US-North Carolina, US-PennsylvaniaUS-New Jersey, US-Virginia, US-Georgia, US-Illinois, US-Michigan, US-Ohio, US-New York, US-Florida, US-North Carolina, US-PennsylvaniaSubmission for the position: Associate Manager Clinical Operations/Manager Clinical Operations/Senior Manager Clinical Operations - Home Based in DE, FL, GA, IL, IN, MI, NC, NJ, NY, OH, PA, RI, VA - (Job Number: 171324)Associate Manager Clinical Operations/Manager Clinical Operations/Senior Manager Clinical Operations - Home Based in DE, FL, GA, IL, IN, MI, NC, NJ, NY, OH, PA, RI, VA


2020-07-13 00:00:00


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