senior initiation clinical research AssociatePAREXEL

Why Work at Parexel
There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?
That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.
How can we help you on your journey? Find your path, and learn more on , , , , and .
Qualifications
Able to take initiative and work independently, and to proactively seek guidance when necessary.
Advance presentation skills.
Client focused approach to work.
Ability to interact professionally within a client organization.
Flexible attitude with respect to work assignments and new learning.
Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to
make decision autonomously due to the unpredictable nature of the issues that arise.
Willingness to work in a matrix environment and to value the importance of teamwork.
Strong computer skills including but not limited to the knowledge of a Clinical Trial Management
System (CTMS), Electronic Document Management System (EDMS), and MS-Office products
such as Excel and Word.
Strong interpersonal, verbal, and written communication skills.
Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country
deliverables.
Effective time management in order to meet study needs, team objectives, and department goals.
Developing ability to work across cultures.
Shows commitment to and performs consistently high quality work.
Ability to successfully work in a ('virtual') team environment.
Consulting Skills
Able to accommodate travel time requirements, according to tasks allocation/phase of the study
assigned.
Attention to detail.
Holds a driver's license where required
Job Description
Build relationships with investigators and site staff.
Conduct, drive and manage country specific feasibility and/or site prequalification and qualification activities, which may include:
o Preparation, negotiation, and facilitation of execution of
Confidentiality Agreements (CDA), Clinical Site Agreements
(CSAs) and any amendments.
o Conduct remote Qualification Visits (QVs).
Generate visit/contact reports, using judgment to identify site issues and
problem solving to direct resolution.
Develop strategy to configure, distribute, and collect, and review and
approve, high quality country specific and/or site specific documents or
essential regulatory documents (SRP) and any updated or amended
regulatory documentation.
Customize, review, and negotiate as needed, country/site specific
Informed Consent Forms (ICF), translations (within parameters of
country/regulatory/client requirements), and customize and negotiate
any amendments.
Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s),
resolving conflicts, determining appropriate follow up until receipt of final
approval.
Submit all pertinent documentation to the trial master file as per project
plans/sponsor/company policy.
Forecast, develop, manage, and revise plans and strategies for:
o IRB/IEC and MoH / RA submission/approval,
o Site activation,
o Patient recruitment & retention.
Update and maintain appropriate Clinical Trial Management systems
(CTMS) in a timely manner.
Promptly identify, use judgment and knowledge to address and resolve
or escalate, any site question and/or issue, including but not limited to:
potential issues or risks with site activation timelines, issues with patient
recruitment strategy, deficiencies in training, data quality or integrity,
study non-compliance, etc.
Facilitate and support allocated sites with access to relevant study
systems and ensure they are compliant with all project specific training
requirements prior to study start.
Actively participate in Investigator and other external or internal
Work in a self-driven capacity, with limited need for oversight.
Proactively keep manager informed about work progress and any
issues.
Build relationships with investigators and site staff.
Facilitate and support site with access to relevant study systems and
ensure sites are compliant with project specific training requirements.
Evaluate if on-site staff assignment is still accurate and determine and
implement corrective actions & follow-up, if necessary / relevant.
Address and resolve issues at sites, including the need for additional
training, potential deficiencies in documentation, and communication.
Address/evaluate/resolve issues pending from the previous visit, if any.
Follow-up on and respond to appropriate site related questions.
Apply working knowledge and judgment to identify and evaluate potential
data quality and data integrity issues. Determine and implement
appropriate follow-up action.
Actively participate in Investigator and other external or internal meetings
and audits & regulatory inspections as required.
Collect, review, and approve (if applicable) updated/amended site
documentation, including regulatory documents as applicable.
Evaluate site recruitment plan in collaboration with the site staff on an
ongoing basis and provide strategy for improvements.
Perform on-site visits; this includes Qualification and Initiation visits;
apply judgment and knowledge to independently resolve site issues,
questions and concerns.
Conduct remote visits/contacts as requested/needed.
Job Family
Clinical Trial Operations
PAREXEL

Manila City, Metro Manila
Permanent
Full-time