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Site Contract Specialist, Czech Republic
PPD Czech Republic, s.r.o.
Place of work
Remote work
Remote work
Contract type
full-time
full-time
Information about the position
Job description, responsibilities and duties
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.
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.
Employee perks, benefits
As a Site Contract Specialist, you will:
Prepares and negotiates contracts, finalizes the contract process. Liaises and establishes effective relationships with sites and internal functional teams. Ensures quality, objectivity, and risk analysis in the efficient delivery of contracts.
Essential Functions:
• Drafts, reviews, negotiates, and finalizes agreements with study sites in accordance with local/accepted process
• 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 sites 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
• Identifies and assesses legal, financial and operational risks and escalates to appropriate level of the organization per established processes
• Provides recommendations and alternative resolutions to Investigator Contract negotiations through established escalation channels
• Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed up timelines; ensure alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation
• Achieve target cycle times for site activations
• Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate.
Job Qualification
To be considered for the role of Site Contract Specialist you will have the following:
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 2-5 years’) or equivalent combination of education, training, & experience.
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Knowledge, Skills and Abilities:
• Understanding 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
• Demonstrated 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 local place of work
• Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters
• 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
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.
Diversity Statement
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
Prepares and negotiates contracts, finalizes the contract process. Liaises and establishes effective relationships with sites and internal functional teams. Ensures quality, objectivity, and risk analysis in the efficient delivery of contracts.
Essential Functions:
• Drafts, reviews, negotiates, and finalizes agreements with study sites in accordance with local/accepted process
• 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 sites 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
• Identifies and assesses legal, financial and operational risks and escalates to appropriate level of the organization per established processes
• Provides recommendations and alternative resolutions to Investigator Contract negotiations through established escalation channels
• Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed up timelines; ensure alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation
• Achieve target cycle times for site activations
• Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate.
Job Qualification
To be considered for the role of Site Contract Specialist you will have the following:
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 2-5 years’) or equivalent combination of education, training, & experience.
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Knowledge, Skills and Abilities:
• Understanding 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
• Demonstrated 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 local place of work
• Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters
• 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
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.
Diversity Statement
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
Requirements for the employee
Candidates with education suit the position
University education (Bachelor's degree)
Language skills
English - Upper intermediate (B2)
Personality requirements and skills
Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) obtain knowledge and master all clinical trial database systems
Advertiser
Brief description of the company
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Number of employees
1000 and more employees
ID: 4207598
Posting date: 19.11.2021
2021-11-19
location: Remote work Position: Regulatory Affairs Specialist Company: PPD Czech Republic, s.r.o.