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Associate, Clinical Trials

3 months ago

Princeton, United States Sun Pharmaceutical Industries Full time

COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE

* Hybrid work arrangement
* Medical, Dental, Vision Benefits
* Health Savings Account (HSA), Flexible Spending Account (FSA)
* Prescription Drug Coverage
* Telehealth and Behavior Health Services
* Income Protection - Short Term and Long Term Disability Benefits
* Retirement Benefits - 401k Company Match on Day One (100% vesting immediately)
* Group Life Insurance
* Wellness Programs
* Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods

Sun Pharma Vision: Reaching People And Touching Lives Globally As A Leading Provider Of Valued Medicines

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 4.5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility.Integrity.Passion.Innovation. It represents our promise to all stakeholders including patients, physicians, and employees.

Our Code of Conduct

Our Global Code of Conduct governs every aspect of our operations. Sun Pharma is a family of thousands of people, working across many countries, speaking multiple languages, and all united, with one common purpose: to make good health accessible and affordable to local communities and society at large. Through active fieldwork, dedicated research teams, and in recognition of the efforts who work behind the scenes to combat illness and disease, the Sun Pharmaceutical Group helps as many people as possible, to secure their right to good health. The way we work every day is important to us.

DOWNLOAD OUR CODE OF CONDUCT

Sun Pharma Advanced Research Company (SPARC) is a pharmaceutical research and drug discovery organization that was formed in 2007 when SUN Pharmaceutical Industries Ltd separated out its active projects in drug discovery and innovation into a new company to provide the focus and the opportunity for growth of these projects which are now at different stages of preclinical and clinical development.

The Clinical Trial Associate will:

* Customize, coordinate with legal team and other stakeholders for finalization of agreements (e.g. CDA, CSA and vendor agreements).
* Assist study team in finalization of Feasibility Questionnaire and co-ordinate with site for completion and track collected information.
* Assist study team in site selection process and document collection.
* Prepare and compile documents for regulatory submission; as applicable.
* Coordinate and/or prepare dossiers for EC submission.
* Coordinate translations of study documents.
* Coordinate with investigators and sites for IM and assist PM in planning for IM, if applicable.
* Perform EC submission related activities including co-ordination with study team and other stakeholders.
* Prepare and dispatch SIV package to sites (including SMF).
* Prepare, maintain and update in a timely manner, the Trial Master File (TMF/eTMF) and the study folder as per SOP/study requirements.
* Co-ordinate with vendor(s) for contracted activities.
* Co-ordinate for procurement, calibration and tracking of Clinical trial supplies including in-house inventory management and ensuring that the sites have all the required supplies at initiation and during the study.
* Co-ordinate for study/team meetings and prepare minutes.
* Update and maintain study trackers & study systems (e.g. CTMS) for the assigned projects.
* Follow up with the study team members/sites/vendors for all the pending documents.
* Support PM for CRO related activities of outsourced studies.
* Coordinate with auditors and study team for audits, CAPA preparation and closure as assigned by FH/PM/LM.
* Initiate and track investigator, site and vendor payments.
* Co-ordinate for study document archival as applicable.
* Complete assigned trainings and maintain updated personal training file.

Qualifications:

* Minimum Bachelor's Degree in a science related field
* Proficient in Microsoft Office (Word, Excel, and PowerPoint)
* Excellent written and verbal communication skills