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MMS Holdings Inc. Manager, Clinical Trial Transparency in Canton, Michigan

MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

Roles & Responsibilities:

  • Ensure compliance with all global applicable laws, regulations and internal policies in regard to Clinical Trial Disclosures

  • Lead carious disclosure activities related to clinical trails

  • Extensive knowledge of PharmaCM Disclosure system is a must

  • Experience administrating ClinicalTrials.gov and EudraCT accounts for clinical trials

  • Deliver updates for all posted clinical trials

  • Act proactively on any Clinical Trial Disclosure topics including, but not limited to, Responsible Data Sharing, Lay Patient Summary or Policy 0070 issues to ensure compliance

  • Provide expert support for internal stakeholders

  • Act as a subject matter expert for a respective Clinical Trial Disclosure training

  • Actively participate in internal and external continuous improvement activities

  • Accountable for management of the vendors responsible for outsourced activities related to Clinical Trial Disclosure activities

  • Support internal audit and inspection activities as required

  • Routinely provide reports of metrics related to tracking and monitoring clinical trial Disclosure activities

  • Approval of the invoices and financial oversight of the vendors responsible for outsourced activities related to Clinical Trial Disclosure and Responsible Data Sharing

  • Contribute to budget planning within the Clinical Trial Transparency Group

  • Oversight of activities performed related to Clinical Trial Disclosure are compliant with applicable laws and in accordance with our global industry trade associations commitments

Requirements:

  • Bachelor?s Degree in Life Science or similar required

  • 5+ years of experience in the clinical development and/or regulatory affairs area within the biopharmaceutical industry or a CRO

  • 2-3 years previous experience in Clinical Trial Transparency is a must

  • Ability to work in an international and cross?functional environment

  • Ability to work independently and possesses good time management skills

  • Knowledge of clinical trial disclosure and responsible data sharing area

  • Comprehensive knowledge of ICH-GCP, FDA, EMA and ROW regulations related to the Clinical Trail Transparency

  • Knowledge of Clinical Trial Disclosure Systems (PahrmaCM)

  • Proven Project Management skills

  • Strong communication skills

  • Solid analytical skills

  • Ability to identify risks and develop mitigation strategies or anticipate and resolve issues even in complex situations

  • Excellent team player

  • Ability to work under high pressure and pronounced resiliency

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