Associate Manager, Centralized Study Operations (Clin Ops)

Associate Manager, Centralized Study Operations (Clin Ops)

Covance India Pharmaceutical Services Private Limited
Bengaluru / Bangalore Mumbai
10 - 12 Years
Not Specified

Job Description

Associate Manager, Centralized Study Operations (Clin Ops)


Essential Job Duties:

  • Responsible for the supervision of assigned direct reports within department
  • Responsible for Detailed performance review and Management of Direct reports including: Annual Performance Management & Development(PMD), Individual Development Plan (IDP), Line of sight goals, Shoves & Tugs.
  • Responsible for appropriate management of performance issues and its resolutions.
  • Measure performance Indicators for assigned staff.
  • Escalate potential Individual training needs and assist in the conduct of training & Development efforts
  • Conduct, report and follow up on quality related issues for direct reports as required
  • Effectively communicate management strategies, policies and procedures in conjunction with leadership teams
  • Communicate status of assigned workload for metric reporting
  • Perform Weekly review of direct report billable hours and associated utilization per the budget plan (Quarterly & annually budget planning). Escalation management about outliers for mitigation.
  • Adhere to goals and objectives.
  • Engage in resource management activities for direct reports
  • Assist with staff recruitment through screening and interviewing
  • Financial authority in accordance with current signature approval matrix.
  • Accountable for expense management, expense report approval and compliance with travel polity/home based policy of direct report.
  • Laisse with all the relevant stake holders in process improvement initiatives including Six Sigma
  • Encourages use of standardized process and tools in alignment with associated policies to ensure efficiency and productivity
  • Schedule Quality review of reporting line work and ensure costs are in alignment with budget as required.Develop and maintain effective relationship with management team to manage assigned staff in a matrix environment

GCP & Quality Oversight:

  • Has GCP oversight of direct reports by ensuring GCP training is completed, understood and implemented.
  • Identify GCP and quality issues though regular interactions with direct report. Plan and execute required action to resolve those issues.
  • Ensure training compliance with training matrix and records are up to date.
  • Provide inputs on relevant SOPs and standard plans/templates for use by Project management and clinical Operations staff.
  • Assist on boarding of new direct reports, this includes conducting and delivering required important job role specific training Ex: GCP, Quality etc.
  • Hold direct reports accountable for GCP issue escalations to the management team, the sponsor or QA as applicable
  • Hold staff accountable for quality and compliance with client SOP, Covance SOP and deliverable timelines.
  • Coach staff on maintaining effective relationship with all the relevant stake holders.

Productivity and Financial Management

  • Maintaining good working relationship with all the relevant stake holders to ensure opportunity for acquiring additional business.

Education/Qualifications:

University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex: Nursing certification, Medical or laboratory technology) and 10+ years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.
1-2 years of people management experience would be an added advantage.
In addition to above, Candidates without life sciences background but with relevant domain knowledge or experience may be considered, if deemed appropriate for specific tasks and activities.

Education/Qualifications:

University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex: Nursing certification, Medical or laboratory technology) and 10+ years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.
1-2 years of people management experience would be an added advantage.
In addition to above, Candidates without life sciences background but with relevant domain knowledge or experience may be considered, if deemed appropriate for specific tasks and activities.
Experience:
Minimum Required:

  • Years of experience in the job discipline: 01-02 Years
  • Years of experience in other professional roles: 10-12 Years
  • Other required work-related experiences:
Act as an SME and lead initiatives
Thought Leader in providing Industry trends
Ability to Influence stakeholders
Mentor Delivery teams and cross departmental synergies
Demonstrated ability to plan, prioritize, organize and communicate effectively.
Demonstrated ability to pay attention to detail.
Strong interpersonal skills with ability to work well with others.
Ability to deliver consistent high quality of work.
Ability to use computer and departmental tools.
Strong interpersonal skills.
Ability to negotiate/Influence with others.
Ability to mentor and train team members.



Covance India Pharmaceutical Services Private Limited

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Functions : Health Care

Industries : Pharmaceutical

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