Jobs · Management · Virginia

Senior Clinical Operations Manager

BioSpace · Shanghai, VA · 3 wk ago
ManagementFull-time
We need to output HTML fragment with headings

for sections present: About the role? Actually job description includes "Company Description", "Job Description", "Responsibilities", "Qualifications", "Additional Information". We should not repeat job title. Use headings for sections that have real content. We need to include sections: About the role? Not present. We have Company Description (maybe "About AbbVie") but we could treat as "Company Description". However instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). They gave examples but we can use other headings if appropriate? Probably we should stick to those headings if content matches. We have "Company Description" not in list; maybe we can omit or put under "About the role"? Not exactly. Could treat as "About the role" includes company description? Might be okay. But better to include a heading "About AbbVie" as

though not in list but instruction says use

for section headings (e.g. About the role, Responsibilities...). It doesn't forbid other headings, but says use

for section headings (e.g. ...). Likely they expect those specific headings if present. We have Responsibilities, Qualifications. Additional Information maybe not needed (EEO boilerplate to remove). We should remove boilerplate like equal opportunity etc. So we will output sections: Responsibilities (

Responsibilities

) with
  • items. Qualifications (

    Qualifications

    ) with
    • . Also maybe a short paragraph for Company Description? Could be placed as

      before sections. Since no heading for it, just a paragraph. We must preserve all substantive information, not invent. Remove duplicated lines. Need to parse responsibilities text and split into bullet points. Let's extract responsibilities from the posting: "Responsible for the hiring, retention, performance management, mentoring, task assignment, growth, and development of their clinical research team. Provide leadership and oversight to the clinical research team including, but not limited to: - performs accompanied visits (on-site and off-site) - accelerates AbbVie's priority programs through close collaboration with internal and external stakeholders - conducts trend analysis and gap assessments to proactively identify training and developmental opportunities for assigned personnel - addresses gaps effectively to help assigned personnel achieve country and site level KPIs and metrics. - Utilizes AbbVie systems and tools to proactively address performance and mitigate risks and issues. - Proactively identifies individual needs of their team members, removes obstacles, proposes solutions, and tailors support to enable successful, on-time monitoring and / or delivery of their assigned study activities. - Ensures adherence to applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research. - Stay abreast of new and/or evolving local regulations, guidelines and policies. - Supports, trains and oversees assigned personnel to ensure that they maintain audit and inspection readiness at assigned sites/studies. - Prepare and follow up on site and country audits, CAPA preparation and implementation. - Accountable For Resource Management For Assigned Team, As Follows Utilizes reports from available systems and country/area model to accomplish In alignment with AbbVie research goals, priorities, an specific study timelines Ensure resource utilization to address business priorities and maximize team impact to delivery of the pipeline. Accountable for the budget management and payments of the assigned studies conducted by their assigned team, as applicable. Creates an inclusive environment to enable team members to reach their full potential. Helps team connect strategy to execution and promotes collaboration with stakeholders to effectively deliver pipeline. Leads and supports the team to understand the business strategy and vision. Drives and implements change through effective communication and management. Partners with research sites with high levels of coordinated and impactful site engagement with KOLs, National Leads, Principal Investigators and site staff positioning AbbVie as the partner of choice in clinical trials. May participate and/or lead global/local task forces and initiatives. Responsible for activities as assigned by Line Manager. Proactively identifies opportunities at local/ global levels and proposes solutions to create efficiencies and streamline/improve processes. Working with the Country COM, may be responsible for resource management of entire country/ies. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie's research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provides solutions. Working with the Country COM, may be responsible for functional budget planning & oversight of expenses across country/ies. Supports the Country COM in conducting country feasibility, implementing site selection strategy, and expanding AbbVie's site footprint within the country. Supports the Country COM in driving insightful and impactful interactions with key R&D external stakeholders and agencies. May be assigned TA responsibility within an affiliate or lead COM's supporting multiple TA's. Support training and monitoring for the team. Develop and implement strategies to support site and KOL / National leaders identification (including in study feasibility) to support Abbvie pipeline execution within the Country or Region. Work with affiliate teams (including Medical Affairs or Commercial brand teams as appropriate) for assigned TA's." That's a lot. We need to turn into bullet list items. Could be many but okay. Qualifications: "Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred. Monitoring Experience: Minimum 5 years plus at least 1 year of direct line management experience preferred. Advanced interpersonal skills with the ability to communicate persuasively with clarity, collaboratively, and cross functionally. Exhibits strong planning and organizational skills. Experience across multiple therapeutic areas and study phases. Excellent mentoring and coaching skills. Has the ability to provide transparent and timely feedback to raise the bar on individual and team performance. Drives innovation and continuous process improvement. Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Deals comfortably with risk and ambiguity, changing course when needed. Ability to make timely, high-quality decisions based on available data and information. Ability to work independently and take initiative/ownership. Ability to adapt and move quickly" We'll bullet each. We also have company description paragraph: "About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube." We need to fix spacing: "atwww.abbvie.com" should be "at www.abbvie.com". Also "Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube." need spaces: "Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube." We'll keep as is but maybe fix minor spacing? The instruction: preserve ALL substantive information; do not invent or summarize away detail. Fixing missing spaces is not inventing; it's correcting formatting but could be considered altering. Safer to keep as given? The text has missing spaces; we could keep exactly as given. However it's ugly but it's the source. I'd keep as given. We must not include boilerplate like equal opportunity etc. So we omit Additional Information. Now produce HTML:

      Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

      Responsibilities

      • Responsible for the hiring, retention, performance management, mentoring, task assignment, growth, and development of their clinical research team.
      • Provide leadership and oversight to the clinical research team including, but not limited to: performs accompanied visits (on-site and off-site)
      • accelerates AbbVie's priority programs through close collaboration with internal and external stakeholders
      • conducts trend analysis and gap assessments to proactively identify training and developmental opportunities for assigned personnel
      • addresses gaps effectively to help assigned personnel achieve country and site level KPIs and metrics.
      • Utilizes AbbVie systems and tools to proactively address performance and mitigate risks and issues.
      • Proactively identifies individual needs of their team members, removes obstacles, proposes solutions, and tailors support to enable successful, on-time monitoring and / or delivery of their assigned study activities.
      • Ensures adherence to applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research.
      • Stay abreast of new and/or evolving local regulations, guidelines and policies.
      • Supports, trains and oversees assigned personnel to ensure that they maintain audit and inspection readiness at assigned sites/studies.
      • Prepare and follow up on site and country audits, CAPA preparation and implementation.
      • Accountable For Resource Management For Assigned Team, As Follows Utilizes reports from available systems and country/area model to accomplish
      • In alignment with AbbVie research goals, priorities, an specific study timelines
      • Ensure resource utilization to address business priorities and maximize team impact to delivery of the pipeline.
      • Accountable for the budget management and payments of the assigned studies conducted by their assigned team, as applicable.
      • Creates an inclusive environment to enable team members to reach their full potential.
      • Helps team connect strategy to execution and promotes collaboration with stakeholders to effectively deliver pipeline.
      • Leads and supports the team to understand the business strategy and vision.
      • Drives and implements change through effective communication and management.
      • Partners with research sites with high levels of coordinated and impactful site engagement with KOLs, National Leads, Principal Investigators and site staff positioning AbbVie as the partner of choice in clinical trials.
      • May participate and/or lead global/local task forces and initiatives.
      • Responsible for activities as assigned by Line Manager.
      • Proactively identifies opportunities at local/ global levels and proposes solutions to create efficiencies and streamline/improve processes.
      • Working with the Country COM, may be responsible for resource management of entire country/ies.
      • Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie's research goals, priorities, and specific study timelines.
      • Proactively identify and communicate issues impacting resource allocation and provides solutions.
      • Working with the Country COM, may be responsible for functional budget planning & oversight of expenses across country/ies.
      • Supports the Country COM in conducting country feasibility, implementing site selection strategy, and expanding AbbVie's site footprint within the country.
      • Supports the Country COM in driving insightful and impactful interactions with key R&D external stakeholders and agencies.
      • May be assigned TA responsibility within an affiliate or lead COM's supporting multiple TA's.
      • Support training and monitoring for the team.
      • Develop and implement strategies to support site and KOL / National leaders identification (including in study feasibility) to support Abbvie pipeline execution within the Country or Region.
      • Work with affiliate teams (including Medical Affairs or Commercial brand teams as appropriate

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