Clinical Study Start-Up Specialist (SSU)
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.
Manages the preparation, review and
coordination of Country Submissions in line with global submission strategy.
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
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
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
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
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
Good judgment and
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
Good organizational and
Excellent knowledge of all
applicable regional / national country regulatory guidelines and EC regulations
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
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
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
Interested applicants are encouraged to send their English CVs/Resume to Steffi.Moses@ppd.com