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Contract Mgr-Study Start Up

Pharmaceutical Product Development (PPD)

US-NC-Morrisville-Morrisville NC 3900 Paramou

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 curveof delivering life-saving therapies to patients.   

Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.

   

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancementopportunities, award winning training and benefits focused on the health and wellbeing of our employees.   

  

Summarized Purpose:

Serves as a regional lead in managing the preparation, negotiation and finalization of contract templates, process and negotiation parameters (including, contractual terms and conditions, and ancillary documents), and oversight of associated investigator grant budget(s), with an assigned workload of clients. Ensures quality, objectivity and risk analysis in the efficient delivery of contract templates, process and negotiation parameters.

Essential Functions:

Leads the review, negotiation, and finalization of contract templates, process and negotiation parameters with clients in accordance with PPD contractual considerations and processes.

Provides regional oversight and contractual risk assessment in accordance with established contractual considerations and serves as the liaison with the legal department during country process improvement initiatives.

Negotiates within approved parameters both investigators grant budget negotiation parameters, contractual terms and conditions in accordance with company contractual considerations, client contractual considerations, established process with clients and follows established escalation routes.

Communicates, trains and provides approved contract templates, process and negotiation parameters and client expectations to assigned team members.

Ensures collaboration, quality alignment with terms and conditions, process and client expectations with assigned team members.

Identifies and assesses legal, financial and operational risks in accordance with approved PPD and client contractual considerations.

Acts as a lead regional interface and escalation contact with external clients for term & condition revisions outside of approved negotiation parameters, client expectations and process deviations. Provides recommendations and alternative resolutions to contract negotiations to internal and external clients.

Works with internal functional departments to facilitate coordination of different site startup activities impacted by contractual activities upon mutually agreed upon timelines. Contributes to or may lead change initiatives within the department.

Completes periodic quality reviews and peer feedback reports.

Creates and delivers training material to team members.

Provides training and mentoring to junior staff.

Qualifications - External Qualifications:

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). 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 roles. Knowledge, Skills and Abilities:

Mastery of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws across several regions Capable of effectively negotiating investigator grant budgets within negotiation parameters

Thorough understanding of business, contractual and financial principles that related to service agreements Strong communication skills (verbal & written) in English and in language spoken at your local place of work. Capable of drafting and negotiating contract provisions and budgetary issues within parameters Strong attention to detail Excellent analytical and decision-based thinking In depth understanding of the clinical drug development and trial process, attained within the pharmaceutical and/or CRO industry Excellent organizational and time management skills to organize competing priorities while monitoring contractual risk and issues. Excellent customer focused style of communication, problem solving and collaboration Proficient in the use of automated systems and computerized applications, such as, Microsoft Outlook, Excel, Word, etc. Excellent problem solving, risk assessment and impact analysis abilities Capable of leading and mentoring others

PPD values the health and well-being 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 ideas with diverse groups of people in a comprehensible and reasonable manner Able to work upright and stationary and/or standing for 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 technology with proficiency May have exposure to potentially hazardous elements typically found in healthcare of laboratory environments Able to perform successfully under pressure while prioritizing

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.  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 curveof delivering life-saving therapies to patients.   

Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.

   

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancementopportunities, award winning training and benefits focused on the health and wellbeing of our employees.   

  

Summarized Purpose:

Serves as a regional lead in managing the preparation, negotiation and finalization of contract templates, process and negotiation parameters (including, contractual terms and conditions, and ancillary documents), and oversight of associated investigator grant budget(s), with an assigned workload of clients. Ensures quality, objectivity and risk analysis in the efficient delivery of contract templates, process and negotiation parameters.

Essential Functions:

Leads the review, negotiation, and finalization of contract templates, process and negotiation parameters with clients in accordance with PPD contractual considerations and processes.

Provides regional oversight and contractual risk assessment in accordance with established contractual considerations and serves as the liaison with the legal department during country process improvement initiatives.

Negotiates within approved parameters both investigators grant budget negotiation parameters, contractual terms and conditions in accordance with company contractual considerations, client contractual considerations, established process with clients and follows established escalation routes.

Communicates, trains and provides approved contract templates, process and negotiation parameters and client expectations to assigned team members.

Ensures collaboration, quality alignment with terms and conditions, process and client expectations with assigned team members.

Identifies and assesses legal, financial and operational risks in accordance with approved PPD and client contractual considerations.

Acts as a lead regional interface and escalation contact with external clients for term & condition revisions outside of approved negotiation parameters, client expectations and process deviations. Provides recommendations and alternative resolutions to contract negotiations to internal and external clients.

Works with internal functional departments to facilitate coordination of different site startup activities impacted by contractual activities upon mutually agreed upon timelines. Contributes to or may lead change initiatives within the department.

Completes periodic quality reviews and peer feedback reports.

Creates and delivers training material to team members.

Provides training and mentoring to junior staff.

Qualifications - External Qualifications:

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). 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 roles. Knowledge, Skills and Abilities:

Mastery of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws across several regions Capable of effectively negotiating investigator grant budgets within negotiation parameters

Thorough understanding of business, contractual and financial principles that related to service agreements Strong communication skills (verbal & written) in English and in language spoken at your local place of work. Capable of drafting and negotiating contract provisions and budgetary issues within parameters Strong attention to detail Excellent analytical and decision-based thinking In depth understanding of the clinical drug development and trial process, attained within the pharmaceutical and/or CRO industry Excellent organizational and time management skills to organize competing priorities while monitoring contractual risk and issues. Excellent customer focused style of communication, problem solving and collaboration Proficient in the use of automated systems and computerized applications, such as, Microsoft Outlook, Excel, Word, etc. Excellent problem solving, risk assessment and impact analysis abilities Capable of leading and mentoring others

PPD values the health and well-being 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 ideas with diverse groups of people in a comprehensible and reasonable manner Able to work upright and stationary and/or standing for 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 technology with proficiency May have exposure to potentially hazardous elements typically found in healthcare of laboratory environments Able to perform successfully under pressure while prioritizing

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. 

Job posted: 2021-04-19

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