Clinical Study Start-Up Specialist (SSU)
Description
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.
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.
Site and Patient Access is a global department working to provide rapid site activation and patient access to our clients. Our innovative approach is designed to help save our clients time and money while driving industry-leading cycle times. Working in Site and Patient Access, you are a very important step in our commitment to industry leadership and the relentless pursuit of excellence.
As a Principal Country Approval Specialist, you will manage the preparation, review and coordination of Country Submissions in line with global submission strategy.
Summarized Purpose:
Manages the preparation, review and coordination of Country Submissions in line with global submission strategy.
Essential Functions:
¡¤ Prepares, reviews and coordinates local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
¡¤ Provides local regulatory strategy advice (MoH & EC) to internal clients.
¡¤ Provides project specific local submission strategy, technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
¡¤ Serves as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.
¡¤ Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.
¡¤ Acts as a key-contact at country level for all submission-related activities.
¡¤ Participates as required in Submission Team Meetings, Review Meetings and Project Team meetings.
¡¤ Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
¡¤ Achieves PPD¡¯s target cycle times for site activations.
¡¤ Works with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
¡¤ Develops country specific Patient Information Sheet/Informed Consent form documents.
¡¤ May assist with grant budgets(s) and payment schedules negotiations with sites.
¡¤ Assists in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions. Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
¡¤ Ensures that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.
¡¤ Oversees country study files and ensures that that they meet PPD WPD¡¯s or client SOP¡¯s.
¡¤ Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
¡¤ Directs/mentors other SIA individuals assigned to support projects of responsibility, as appropriate.
¡¤ Prepares and maintains country master document templates and other PPD regulatory intelligence systems, as may be required and assigned
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 sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
¡¤ Effective oral and written communication skills
¡¤ Excellent interpersonal skills
¡¤ Strong attention to detail and quality of documentation
¡¤ Solid negotiation skills
¡¤ Good computer skills and the ability to learn appropriate software
¡¤ Good English language and grammar skills
¡¤ Good judgment and decision-making skills
¡¤ Basic medical/therapeutic area and medical terminology knowledge
¡¤ Ability to work in a team environment or independently, with minimal supervision, as required
¡¤ Ability to mentor fellow SIA team members in a positive and effective manner
¡¤ Excellent team player with teambuilding skills
¡¤ Good organizational and planning skills
¡¤ Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations
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
We believe flexibility is an expectation, not something that is earned. That¡¯s why work setting decisions here are based on individual preference and your role. We offer three work setting options designed to give you the maximum amount of flexibility your role allows – Home-based, Office-based & Flex (3 days office-based and 2 days home-based)
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.
Interested applicants are encouraged to send their English CVs/Resume to Steffi.Moses@ppd.com
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