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Associate Manager, SSU

Laboratory Corporation of America Holdings (Covance)

Petaling Jaya, Malaysia

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 11.0pt;">The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. Ability to indirectly influence investigators, vendors, external partners and country managers to deliver these commitments is a must. This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country based regulations, laws and procedures with minimal support from the client management. The position requires skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment, submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables.</span></p><p style="margin: 0px;"><span style="font-size: 11.0pt;">The position requires the ability to proactively develop risk management and mitigation plans in the country and resolve issues locally<em>.</em></span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><u><span style="font-size: 11.0pt;">On the Client level:</span></u></p><p style="margin: 0px;"><span style="font-size: 11.0pt;"> </span></p><p style="margin-left: .5in;"><span style="font-size: 11.0pt;">FINANCIAL (as applicable): </span></p><ul><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Assistance with the ownership of country and site budgets. </span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value. </span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Oversight and tracking of clinical research-related payments</span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Payment reconciliation at study close-out.</span></li></ul><p style="margin: 0px;"><span style="font-size: 11.0pt;"> </span></p><p style="margin-left: .5in;"><span style="font-size: 11.0pt;">COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS (as applicable): </span></p><ul><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.</span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Development of local language materials including local language Informed Consents and translations. </span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.</span></li></ul><p style="margin: 0px;"><span style="font-size: 11.0pt;"> </span></p><p style="margin-left: .5in;"><span style="font-size: 11.0pt;">MANAGEMENT & QUALITY OVERSIGHT: </span></p><ul><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. </span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Contributes to the development of local SOPs. </span></li></ul><p style="margin: 0px;"><span style="font-size: 11.0pt;"> </span></p><p style="margin-left: .5in;"><span style="font-size: 11.0pt;">COLLABORATION: </span></p><ul><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Works in close collaboration internally with Clinical country operations (CRD, CRM,CTC,CRA), Country Quality Manager (CQM), Finance, Medical Affairs, Regulatory Affairs, PharmacoVigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. </span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.</span></li></ul><p style="margin: 0px;"><span style="font-size: 11.0pt;"> </span></p><p style="margin-left: .5in;"><span style="font-size: 11.0pt;">LOCAL PROCESS OVERSIGHT: (as applicable):</span></p><ul><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. </span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Enters and updates country information in clinical, regulatory, safety and finance systems.</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">In lieu of the above requirement, candidates with minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting  will be considered</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Thorough understanding of the drug development process</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Fluent in local office language and in English, both written and verbal</span></li></ul><h2>Experience:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Good organizational and time management skills</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Excellent communication skills, oral and written.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Self-motivation with the ability to work under pressure to meet deadlines</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Works well independently as well as in team environment.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Detail and process oriented</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Positive attitude and approach</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Interact with internal and external customers with high degree of professionalism and discretion</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Multi-tasking capability.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Good computer skills with good working knowledge of a range of computer packages</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Ability to lead and develop junior staff</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Flexible and adaptable to a developing work environment</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Minimum of four-six (4-6) years of clinical research experience</span></li></ul>

Job posted: 2021-08-18