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Senior Feasibility and Site Liaison Specialist

Pharmaceutical Product Development (PPD)

Multiple Locations

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 start-up 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 start-up timelines and exceed expectations.

We are currently seeking a Senior Feasibility & Site Liaison Specialist join our team in Germany. This role represents PPD in the global medical research community. Develops and maintains collaborative relationships with investigators and site personnel to conduct feasibility assessments in accordance with feasibility processes and within deliverable timelines. Uses and enhances therapeutic expert knowledge to optimize site collaboration. Assesses and develops optimized feasibility strategies for Austria, Germany and Switzerland in close collaboration with local SIA team. Develops a local knowledge base of sites in the respective market through collaborative working with local PPD personnel. Utilizes local knowledge, PPD systems, external site lists and sponsor directives to develop and review site lists that are suitable for the strategic needs of the feasibility and for the specific project design/requirements. Provides local input into the site tiering process as well as country-specific intelligence, expertise and experience on particular therapeutic areas/research landscape, SoCs, country/site mix, patient population, KOLs, etc. in order to support Business Development and RFPs queries. Establishes and develops closer collaboration with local Networks and Study Groups.

The responsibilities of this role are:

• Implement feasibility assessments.

• Develop site lists, including research from internal and external sources to ensure the site list is reflective of the defined site profile. Ensures current investigator and site staff contact details are appropriately maintained in PPD systems.

• Ensure completion of the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel using gB Select. Documents in real time all communication, attempts and follow up associated with site contact and survey responses.

• Review survey data to ensure responses are logical, complete and reflective of the question asked.

• Work in collaboration with SF Specialist to achieve targeted response goals for assigned projects.

• Communicate with the Strategic Feasibility team, appropriate SI&A and clinical personnel regarding site issues and feasibility risks.

• Serve as the Lead ‘FSLA’ when multiple resources are assigned to a project.

• Coordinate activity to ensure an efficient, effective plan is in place for site contact and follow up.

• Oversee the resource(s) to ensure compliance with the plan and escalate performance concerns/non-compliance to SF Specialist and SF Manager.

• Serve as the local expert regarding site capacity and expertise. Work with key local personnel to gather knowledge base and recommend additional sites.

• Harness this knowledge base when performing local tiering of sites.

• Where applicable, develops and maintains relationship with client local affiliates.

• Champion the inclusion of Strategic Collaboration sites into the feasibility process.

• Conduct phone interviews, scripted or non-scripted, with physicians and other site personnel to discuss standard of care and obtain protocol-level input to support trial optimization projects.

• Liaise with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information.

• Contribute to the development and roll out of global strategic feasibility processes and best practices.

“Severely disabled applicants with the same aptitude will be given preferential treatment. / Schwerbehinderte Bewerber werden bei gleicher Eignung bevorzugt behandelt.”

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 start-up 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 start-up timelines and exceed expectations.

We are currently seeking a Senior Feasibility & Site Liaison Specialist join our team in Germany. This role represents PPD in the global medical research community. Develops and maintains collaborative relationships with investigators and site personnel to conduct feasibility assessments in accordance with feasibility processes and within deliverable timelines. Uses and enhances therapeutic expert knowledge to optimize site collaboration. Assesses and develops optimized feasibility strategies for Austria, Germany and Switzerland in close collaboration with local SIA team. Develops a local knowledge base of sites in the respective market through collaborative working with local PPD personnel. Utilizes local knowledge, PPD systems, external site lists and sponsor directives to develop and review site lists that are suitable for the strategic needs of the feasibility and for the specific project design/requirements. Provides local input into the site tiering process as well as country-specific intelligence, expertise and experience on particular therapeutic areas/research landscape, SoCs, country/site mix, patient population, KOLs, etc. in order to support Business Development and RFPs queries. Establishes and develops closer collaboration with local Networks and Study Groups.

The responsibilities of this role are:

• Implement feasibility assessments.

• Develop site lists, including research from internal and external sources to ensure the site list is reflective of the defined site profile. Ensures current investigator and site staff contact details are appropriately maintained in PPD systems.

• Ensure completion of the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel using gB Select. Documents in real time all communication, attempts and follow up associated with site contact and survey responses.

• Review survey data to ensure responses are logical, complete and reflective of the question asked.

• Work in collaboration with SF Specialist to achieve targeted response goals for assigned projects.

• Communicate with the Strategic Feasibility team, appropriate SI&A and clinical personnel regarding site issues and feasibility risks.

• Serve as the Lead ‘FSLA’ when multiple resources are assigned to a project.

• Coordinate activity to ensure an efficient, effective plan is in place for site contact and follow up.

• Oversee the resource(s) to ensure compliance with the plan and escalate performance concerns/non-compliance to SF Specialist and SF Manager.

• Serve as the local expert regarding site capacity and expertise. Work with key local personnel to gather knowledge base and recommend additional sites.

• Harness this knowledge base when performing local tiering of sites.

• Where applicable, develops and maintains relationship with client local affiliates.

• Champion the inclusion of Strategic Collaboration sites into the feasibility process.

• Conduct phone interviews, scripted or non-scripted, with physicians and other site personnel to discuss standard of care and obtain protocol-level input to support trial optimization projects.

• Liaise with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information.

• Contribute to the development and roll out of global strategic feasibility processes and best practices.

“Severely disabled applicants with the same aptitude will be given preferential treatment. / Schwerbehinderte Bewerber werden bei gleicher Eignung bevorzugt behandelt.”

Education/Experience:

Bachelor’s Degree in life sciences or related field or certification in a related allied health profession from an appropriately accredited institution (i.e.: RN, MT, PA, RPh, RT) or equivalent and relevant formal academic / vocational qualification

• Experience as a clinical research monitor or feasibility specialist., or extensive experience as a research/project assistant that provides the knowledge, skills, and abilities to perform the job (typically 2 years’ experience required)

Knowledge, Skills and Abilities:

• Excellent oral and written communication skills, with the ability to communicate effectively with medical personnel• Excellent interpersonal skills• Strong attention to detail and quality of documentation• Good negotiation skills• Good computer skills and the ability to learn appropriate software• Fluency in local language as well as a good command of the English language and grammar skills• Good medical/therapeutic area and medical terminology knowledge• Ability to work in a team environment or independently, under direction, as required• Excellent organizational and planning skills (multiple projects, tight timelines)• Basic knowledge of local health systems• Ability to attain and maintain a working knowledge of GCP and applicable SOPs• Excellent customer focus• Proven flexibility and adaptability• Ability to work in a matrix environment• A proven relationship builder• An independent thinker• Ability to manage risk and perform risk escalation appropriately

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.*LI-SH1

Education/Experience:

Bachelor’s Degree in life sciences or related field or certification in a related allied health profession from an appropriately accredited institution (i.e.: RN, MT, PA, RPh, RT) or equivalent and relevant formal academic / vocational qualification

• Experience as a clinical research monitor or feasibility specialist., or extensive experience as a research/project assistant that provides the knowledge, skills, and abilities to perform the job (typically 2 years’ experience required)

Knowledge, Skills and Abilities:

• Excellent oral and written communication skills, with the ability to communicate effectively with medical personnel• Excellent interpersonal skills• Strong attention to detail and quality of documentation• Good negotiation skills• Good computer skills and the ability to learn appropriate software• Fluency in local language as well as a good command of the English language and grammar skills• Good medical/therapeutic area and medical terminology knowledge• Ability to work in a team environment or independently, under direction, as required• Excellent organizational and planning skills (multiple projects, tight timelines)• Basic knowledge of local health systems• Ability to attain and maintain a working knowledge of GCP and applicable SOPs• Excellent customer focus• Proven flexibility and adaptability• Ability to work in a matrix environment• A proven relationship builder• An independent thinker• Ability to manage risk and perform risk escalation appropriately

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.*LI-SH1

Job posted: 2020-12-10

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