Clinical Trials Start-Up/Operations Associate

Job DescriptionClinical Trials Start-Up/Operations AssociateLooking for a different challenge as an Clinical Trials Start-Up/Operations Associate whereby you can still utilise your skills?Permanent Full-time position with competitive renumeration and benefitsLocation: Macquarie Park, SydneyModern office environment, a dedicated and welcoming teamUpskill and growth in an area your passionate about, whilst being fully supported and encouraged.Join a trusted Global leading organisationX2 Associate Clinical Operations Manager positions available in SydneyThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for Supporting budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals.What You Will DoResponsibilities include, however not limited to:Support to country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).Oversees and tracks clinical research-related payments. Payment reconciliation at study close- out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Support of Financial forecasting in conjunction with Sr.COM /other roles.Contribute to Execution and oversight of clinical trial country submissions and approvals for assigned protocols.Develops working knowledge of local language materials including local language Informed Consents and translations. May interact with Regulatory Authority for assigned protocols.Supports country deliverables, timelines, and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.Contributes to the development of local SOPs.Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.Provide support to local vendors as applicable.Support local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements. Enters and updates country information in clinical and finance systems.Support of local regulatory and financial compliance.Acquire knowledge how to in/directly influence investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related- interactions with support of an experienced COM. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.Contribute to initiatives and projects adding value to the business, as appropriate/required.Contributes to COM team and other Country Operations roles knowledge by acting as/supporting process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement as appropriate/required.Contributes to COM team knowledge by sharing best practices as appropriate/required.What You Must haveExperience in Clinical Research or experience in Finance/BusinessRequired: Associate Degree or equivalent Health Care related experiencePreferred: Bachelor’s degreeRequired Skills:Good IT skills (MS office, Clinical IT applications) and ability to adapt to new IT applications on various devices.Excellent verbal and written skills, in local language and EnglishStrong coordination and organizational skillsBasic knowledge of budget and contract negotiation process, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.Ability to propose solutions to local study teams.ICH/GCP knowledge appropriate to role. Hands on knowledge of Good Documentation PracticesAble to work with other experienced clinical research professionals to learn and develop skills to manage protocols independently. Works with high quality and compliance mindset.What You Can ExpectWork autonomously whilst being supported, encouraged and being part of a trusted Global leading Pharmaceutical organisationExposure to upskill and develop in your roleFlexibility and opening doors to other opportunities and skillsetsJoining a collaborative team of likeminded individualsWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Current Employees applyCurrent Contingent Workers applySearch Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements: Not ApplicableShift:Valid Driving License:Hazardous Material(s):Job Posting End Date: 06/3/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.