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Assoc Site Contract Spec

Pharmaceutical Product Development (PPD)

United States

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.  

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. 

As an Associate Site Contract Specialist you will assist in the preparation, negotiation and finalization of contracts with investigative sites.

  

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:

Assists in the preparation, negotiation and finalization of contracts with investigative sites. Liaises and establishes effective relationships with internal functional teams.

Essential Functions:

Drafts, reviews, negotiates and finalizes amendments and budgets with study sites in accordance with local/accepted process Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with contractual considerations, client contractual considerations, established process with clients and follows established escalation routes Ensures compliance to established negotiation parameters, authority approval, contractual process and client expectations Ensures compliance of budgetary guidance, templates and process Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines; ensures alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation. Achieves target cycle times for site activations. Ensures guidelines and processes are followed for efficient escalation of out of parameter issues, as applicable. Completes tracking and reporting as required and assists all other specialists with tracking and reporting as required. 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.  

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. 

As an Associate Site Contract Specialist you will assist in the preparation, negotiation and finalization of contracts with investigative sites.

  

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:

Assists in the preparation, negotiation and finalization of contracts with investigative sites. Liaises and establishes effective relationships with internal functional teams.

Essential Functions:

Drafts, reviews, negotiates and finalizes amendments and budgets with study sites in accordance with local/accepted process Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with contractual considerations, client contractual considerations, established process with clients and follows established escalation routes Ensures compliance to established negotiation parameters, authority approval, contractual process and client expectations Ensures compliance of budgetary guidance, templates and process Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines; ensures alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation. Achieves target cycle times for site activations. Ensures guidelines and processes are followed for efficient escalation of out of parameter issues, as applicable. Completes tracking and reporting as required and assists all other specialists with tracking and reporting as required. 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 0-2 years).

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:

Basic understanding of clinical trial agreements Basic ability to apply basic principles of investigator grant negotiation General understanding of business and financial principles that related to service agreements Effective communication skills (verbal and written) in English and in language spoken at your local place of work. Strong attention to detail Excellent analytical and decision based thinking Understanding of the pharmaceutical product development process and involvement of CROs Able to work independently or in a team environment Good organizational and time management skills Working knowledge of PPD SOP and WPDs Able to organize competing priorities logically and review outstanding contractual risk and issues Able to effectively use automated systems and computerized applications, such as, Microsoft Outlook, Excel, Word, etc. Ability to demonstrate a customer focused style of communication, problem solving and collaboration 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 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 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'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 0-2 years).

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:

Basic understanding of clinical trial agreements Basic ability to apply basic principles of investigator grant negotiation General understanding of business and financial principles that related to service agreements Effective communication skills (verbal and written) in English and in language spoken at your local place of work. Strong attention to detail Excellent analytical and decision based thinking Understanding of the pharmaceutical product development process and involvement of CROs Able to work independently or in a team environment Good organizational and time management skills Working knowledge of PPD SOP and WPDs Able to organize competing priorities logically and review outstanding contractual risk and issues Able to effectively use automated systems and computerized applications, such as, Microsoft Outlook, Excel, Word, etc. Ability to demonstrate a customer focused style of communication, problem solving and collaboration 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 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 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

Job posted: 2020-09-28

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