Principal Centralized Monitoring Analyst

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.

PPD's data analytics group delivers a new approach to risk surveillance and centralized statistical monitoring, combining the power of statistical and analytical tools with expertise from operationally experienced staff to monitor and manage clinical study data. Data analytics staff explores study data holistically to pinpoint meaningful signals, resulting in more efficient and effective issue resolution and a proactive approach to risk detection. Using this data-driven approach, PPD can address study problems or site performance quickly, directing remediation activities where needed and positioning on-site monitoring activity in a targeted approach.

Data analytics is an integral part of PPD’s risk-based monitoring (RBM) strategy and supports centralized monitoring efforts. Ongoing data assessments from our data analytics group allows to adapt monitoring plans dynamically so that CRAs can focus on the factors that have the greatest impact on data integrity and subject safety. Regardless of the percentage of source data verification (SDV), the data analytics group's centralized statistical monitoring approach identifies risk signals that may be difficult to detect through traditional review methods, such as on-site monitoring.

Data analytics evaluates data within and across studies, sites, countries and regions. Our analytic approach provides insight into: Data errors, deviations Trends, outliers Unusual variation (or lack of variation) Potential data manipulation, fraud Other systematic errors or data integrity issues.

As a Principal CM Analyst, you’ll act as the lead subject matter expert and interdepartmental and client liaison for data analytics activities.

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:

Acts as the lead subject matter expert and interdepartmental and client liaison for data analytics activities. Area of focus may be a data analytics specialty, focusing on the development of complex tools and processes to detect, investigate, diagnose and mitigate issues and risks, engaging cross-functional subject matter experts to support development, or as a project lead, leading multiple, high volume, extremely complex projects/programs, including set-up of functional plans, tools and delivery of review cycles.

Essential Functions:

Ensures performance of assigned reviews with high quality, on-time results with more complex analyses or deeper root cause analyses to connect related signal to risks.

Provides training and guidance to junior team members.

May participate in a project lead or development specialist role, or a combination of both.

Project leadership activities include: Independently leads the design and setup of study specific tools and centralized monitoring plan for data review; manages review timelines, develops analysis assignments for team, and supports budget management; organizes, communicates with internal team, and delegates as appropriate to ensure reviews are completed on-time, on budget, with high quality; leads report development, delivers reports, and leads centralized monitoring meetings; contributes to risk assessment through the completion of the department risk assessment tools. Participates in the cross-functional risk assessment review meetings and contributes to overall risk planning.

Specialist activities include leading efforts to development of new tools and analyses within area of specialty, including complex and collaborative approaches with other functions (such as biostatistics, medical monitoring, etc.).

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.

PPD's data analytics group delivers a new approach to risk surveillance and centralized statistical monitoring, combining the power of statistical and analytical tools with expertise from operationally experienced staff to monitor and manage clinical study data. Data analytics staff explores study data holistically to pinpoint meaningful signals, resulting in more efficient and effective issue resolution and a proactive approach to risk detection. Using this data-driven approach, PPD can address study problems or site performance quickly, directing remediation activities where needed and positioning on-site monitoring activity in a targeted approach.

Data analytics is an integral part of PPD’s risk-based monitoring (RBM) strategy and supports centralized monitoring efforts. Ongoing data assessments from our data analytics group allows to adapt monitoring plans dynamically so that CRAs can focus on the factors that have the greatest impact on data integrity and subject safety. Regardless of the percentage of source data verification (SDV), the data analytics group's centralized statistical monitoring approach identifies risk signals that may be difficult to detect through traditional review methods, such as on-site monitoring.

Data analytics evaluates data within and across studies, sites, countries and regions. Our analytic approach provides insight into: Data errors, deviations Trends, outliers Unusual variation (or lack of variation) Potential data manipulation, fraud Other systematic errors or data integrity issues.

As a Principal CM Analyst, you’ll act as the lead subject matter expert and interdepartmental and client liaison for data analytics activities.

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:

Acts as the lead subject matter expert and interdepartmental and client liaison for data analytics activities. Area of focus may be a data analytics specialty, focusing on the development of complex tools and processes to detect, investigate, diagnose and mitigate issues and risks, engaging cross-functional subject matter experts to support development, or as a project lead, leading multiple, high volume, extremely complex projects/programs, including set-up of functional plans, tools and delivery of review cycles.

Essential Functions:

Ensures performance of assigned reviews with high quality, on-time results with more complex analyses or deeper root cause analyses to connect related signal to risks.

Provides training and guidance to junior team members.

May participate in a project lead or development specialist role, or a combination of both.

Project leadership activities include: Independently leads the design and setup of study specific tools and centralized monitoring plan for data review; manages review timelines, develops analysis assignments for team, and supports budget management; organizes, communicates with internal team, and delegates as appropriate to ensure reviews are completed on-time, on budget, with high quality; leads report development, delivers reports, and leads centralized monitoring meetings; contributes to risk assessment through the completion of the department risk assessment tools. Participates in the cross-functional risk assessment review meetings and contributes to overall risk planning.

Specialist activities include leading efforts to development of new tools and analyses within area of specialty, including complex and collaborative approaches with other functions (such as biostatistics, medical monitoring, etc.).

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years’). Prior experience in clinical monitoring, data management, biostatistics or related field in support of clinical trials is preferred.

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered enough for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

Ca pa ble of a pplyin g t h o ro u gh k n ow le dge a n d s k ills i n a h ighly orga n ize d f a sh io n w h ile a dhering t o re gulat ory gu ide lin e s, gl oba l SOPs a n d cl ie n t e xpe c ta tio n s

Strong a tte n tio n t o de ta il w ith profi c ie n t orga n iza tion a n d m u lti -ta s k in g s k ills

E xc e lle n t a n a ly ti c a l / proble m -solv i n g s kills /j u dgme n t i n de c isio n ma k i n g

Ab ilit y t o lea d, motiva te an d coo rdi n a te tea ms, inc l u di n g coac h in g/ me n toring tea m me mbe rs

D e mon stra te d a bilit y t o ma i n ta in a h igh de gre e of c on f i de n tia lity w ith cl i n ic a l da ta a n d client' s proprie ta ry da ta

So u n d inte rpe rso n a l sk i lls w ith prove n f le xib ilit y a n d a d a pta bilit y t o ch a n gi n g sit u a tion s

Strong ora l a n d w rit te n co mmun ic a tio n s k ills (E n glis h ) w ith t h e prove n a bilit y t o c omm un i c a te e ff e c ti v e ly w ith a v a rie ty o f in te rnal a n d e xte rnal cu sto me rs, inc l u ding proje c t tea m, f u nc tio n a l ma n a ge me n t a n d client c on ta c ts

Strong c omp u te r s k ills, w ith stron g k n ow le dge o f MS Off i c e (W ord, E x c e l, Powe rP o in t) a n d t h e a bilit y to lea rn an d use i n te ra c tiv e co mpute r s y ste ms

D e mon stra te d a bilit y t o e xt ra c t pe rt in e n t in f orma tion f rom sta n da r d st u d y doc u m e n ta tion , s uc h a s

prot oc ols , ele c tro n ic st u dy da ta sy ste ms a n d t o ide n ti f y t re n ding of site/ stu dy da t a

E xc e lle n t k n ow le dge a n d a pplica tion o f re so u rce ma n a ge me n t a n d pla nn i n g.

Knowle dge of t h e k e y co mp on e n ts o f pro j e c t ma n a ge m e n t princ iple s of T ime , C ost , Qualit y

Ap plie s a ra n ge of n e got ia tion te c h n ique s w ith e v ide n c e of co mme r c ia l a n d orga n i za tion a l a cu me n t o e ff e c ti v e ly n e got ia te (pe rsu a de , c on v in c e , in f lu e nc e ) a n d a ch ie v e de sire d ou t c om e s in te rnally an d e xte rnally

D e mon stra te d a bility t o ser v e a s a su bj e c t ma tte r e xpe r t a n d lea d on pro j e c ts c ross -f u nc tio n a lly , inc lu ding de le ga tin g a n d effe c tiv e ly pri oritizing i n divid u a l a n d tea m w orkl oa d

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:

Able to communicate, receive, and understand information and ideaswith diverse groups of peoplein a comprehensible and reasonable manner.

Ableto work upright and stationary and/or standingfor typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technologywith proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

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

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.

IndeedPPDUS

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#PPDHP

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Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years’). Prior experience in clinical monitoring, data management, biostatistics or related field in support of clinical trials is preferred.

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered enough for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

Ca pa ble of a pplyin g t h o ro u gh k n ow le dge a n d s k ills i n a h ighly orga n ize d f a sh io n w h ile a dhering t o re gulat ory gu ide lin e s, gl oba l SOPs a n d cl ie n t e xpe c ta tio n s

Strong a tte n tio n t o de ta il w ith profi c ie n t orga n iza tion a n d m u lti -ta s k in g s k ills

E xc e lle n t a n a ly ti c a l / proble m -solv i n g s kills /j u dgme n t i n de c isio n ma k i n g

Ab ilit y t o lea d, motiva te an d coo rdi n a te tea ms, inc l u di n g coac h in g/ me n toring tea m me mbe rs

D e mon stra te d a bilit y t o ma i n ta in a h igh de gre e of c on f i de n tia lity w ith cl i n ic a l da ta a n d client' s proprie ta ry da ta

So u n d inte rpe rso n a l sk i lls w ith prove n f le xib ilit y a n d a d a pta bilit y t o ch a n gi n g sit u a tion s

Strong ora l a n d w rit te n co mmun ic a tio n s k ills (E n glis h ) w ith t h e prove n a bilit y t o c omm un i c a te e ff e c ti v e ly w ith a v a rie ty o f in te rnal a n d e xte rnal cu sto me rs, inc l u ding proje c t tea m, f u nc tio n a l ma n a ge me n t a n d client c on ta c ts

Strong c omp u te r s k ills, w ith stron g k n ow le dge o f MS Off i c e (W ord, E x c e l, Powe rP o in t) a n d t h e a bilit y to lea rn an d use i n te ra c tiv e co mpute r s y ste ms

D e mon stra te d a bilit y t o e xt ra c t pe rt in e n t in f orma tion f rom sta n da r d st u d y doc u m e n ta tion , s uc h a s

prot oc ols , ele c tro n ic st u dy da ta sy ste ms a n d t o ide n ti f y t re n ding of site/ stu dy da t a

E xc e lle n t k n ow le dge a n d a pplica tion o f re so u rce ma n a ge me n t a n d pla nn i n g.

Knowle dge of t h e k e y co mp on e n ts o f pro j e c t ma n a ge m e n t princ iple s of T ime , C ost , Qualit y

Ap plie s a ra n ge of n e got ia tion te c h n ique s w ith e v ide n c e of co mme r c ia l a n d orga n i za tion a l a cu me n t o e ff e c ti v e ly n e got ia te (pe rsu a de , c on v in c e , in f lu e nc e ) a n d a ch ie v e de sire d ou t c om e s in te rnally an d e xte rnally

D e mon stra te d a bility t o ser v e a s a su bj e c t ma tte r e xpe r t a n d lea d on pro j e c ts c ross -f u nc tio n a lly , inc lu ding de le ga tin g a n d effe c tiv e ly pri oritizing i n divid u a l a n d tea m w orkl oa d

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:

Able to communicate, receive, and understand information and ideaswith diverse groups of peoplein a comprehensible and reasonable manner.

Ableto work upright and stationary and/or standingfor typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technologywith proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

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

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.

IndeedPPDUS

IndeedPPDClin

#PPDHP

*LI-OD1