Associate Director, Strategic Partner - Home Based

Company: Labcorp
Location: Miami
Posted on: October 12, 2021

Job Description:

Job Overview:

Associate Director, Strategic Partner

US or Canada Remote Based Role

The Associate Director, Strategic Partner is a key role within our matrix organisation, accountable for all activities such as Quality Oversight & Management, Operational Performance, Financial Delivery and Talent retention & development, representing the company both internally and externally to clients and regulatory bodies. Experience with portfolio oversight and delivery.  Ability to use strong critical thinking, analysis, and problem-solving skills in order to maintain active inspection readiness across assigned TMF portfolio(s). Ability to work collaboratively with study teams to develop remediation plans for non-compliant TMFs.  Experience using and managing eTMF; specifically Veeva Vault eTMF, and other Clinical Trial Related Systems. Knowledge of the TMF reference model. Working knowledge of industry standards surrounding creation, maintenance and archiving of TMF. Working knowledge of Health Authority expectations regarding TMF inspection readiness.

Responsibilities:

• Support Client meetings by representing the function or countries or region with no local Management (this includes identifying or recruiting staff)
• Represent main point of contact for local clients and new business opportunities
• Act in a Lead Line Manager capacity for a specific client where required
• Responsible for the preparation of Labcorp Drug Development office audits by local or central regulatory authorities and clients. Acts as contact for local regulatory authorities
• Act as main point of contact for local clients Leadership
• Drive department resourcing strategy within designated area of responsibility including ensuring the right talent are assigned to the right projects at the right time; ensure that the talent is fully utilised
• Effective leader in a matrix organisation and demonstrates ability to influence peers and other departments
• Effectively lead in a complex environment, set clear expectations, coach and mentor for success, consistently communicate and connect, foster a continuous learning environment
• An inspiring leader that is an effective line manager that attracts, selects, on-boards, develops and retains high performing talent; strengthens and deepens talent bench and succession
• Partner with other functions HR, Legal, etc. Provide input on salary adjustments / proposals and functional levels; recognise local labour market conditions that affect compensation and incorporate knowledge of such conditions into recommended salary changes
• Drive relevant process improvement initiatives
• Represent Labcorp Drug Development Leadership to external parties within the country(ies) of responsibility
• Network and share business development opportunity information with other Labcorp Drug Development functions
• Support bid-defense meetings as an expert of their country or cluster of countries
• May manage assignments of third-party (sub CRO) employees within area of responsibility
• Define strategies with the global Regulatory group and the Project management teams in managing local and/or regional regulatory matters
• Have overall accountability for legal and regulatory requirement compliance through working with/employing local regulatory experts
• Participate in internal/external audits, regulatory agency inspections, as required
• Act in a Lead Line Manager capacity for specific country(ies) where required
• Is accountable and responsible for execution of the country and/or regional quality plan(s) and delivery on country quality metrics and quality delivery

• Hold employees within the area of responsibility accountable for compliance to productivity and quality metrics and/or dashboard objectives such as deliver site identification, start-up, patient enrolment, data cleaning and related objectives

• Ensure that staff and teams meet project delivery directives

• Coach staff to own effective investigator relations and investigator oversight at the local and/or regional level

• Liaise with management at other locations and Leadership to identify and implement opportunities for standardisation of process and increased efficiency within and between departments

• Ensure that staff and teams maintain effective levels of communication and working relationships with all other departments

• Identify strategic staffing needs and assist in staff recruitment

• Drive the use of standardised processes and tools in alignment with associated policies to ensure efficiency and productivity

• Facilitate problem-solving for the area of responsibility, own and execute corrective and preventative action.

• Accountable to ensure adherence to new regulatory information and changes to local drug law

• Oversee to "at risk" sites identification, rate site risk criteria and determine prioritisation of CQC visits in the country

• May act as back-up for the next level management duties

• Perform other duties as required by Management

• Responsible for selection, training, development and performance management for assigned staff

• Ensure that the assigned staff work to the highest standard in compliance with current SOPs, relevant guidelines/policies and regulatory requirements
• Ensure GCP and training record compliance for self and direct reports with training matrix and ensure training records are up-to-date
• Provide input to relevant SOPs and standard plans/templates when applicable
• Hold staff accountable for the development, implementation and adherence to relevant SOPs and guidelines
• Responsible for candidate selection and interviews for key positions within departments
• Promote a Culture of Individual Development & Mentoring, leading by example
• Implement strategies to achieve the divisions’ productivity goals
• Support the maximisation of the profitability of operations ensuring that all deliverables are met on time
• Responsible for optimising financial performance. Influence and explain the overall productivity of the functional business units
• Monitor cost overruns, including headcount growth. Propose and agree with relevant functional managers’ strategies for delivering savings or remedies for issues observed
• Monitor and assess with relevant functional managers staff allocation within the country(ies)
• Be prepared to contribute to the annual budget preparation in cooperation with Finance Director and Regional and Global Functional Heads
• Partner with BD to identify local / regional opportunities
• Support Contracts & Legal Budget for statutory documents preparation and signature as needed
• Manage status of assigned workload for resource needs on a country and/or regional level
• Responsible and accountable for billable hours and associated utilisation in the area of responsibility. Escalate outliers, provide recommendations and take necessary actions assist the management team with mitigation
• Execute financial authority in accordance with current signature approval matrix
• Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports
• Develop and grow the business in the country and/or region by advising global and local managers of cross-functional opportunities

Education/Qualifications:

Required:

University/college degree – life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)

Preferred:

• Masters or other advanced degree from an appropriately accredited institution

In lieu:

• Minimum of seven (7) years supervisory experience in a health care or clinical research setting and minimum of ten (10) years relevant clinical research experience in a pharmaceutical company/CRO

Experience:

Minimum Required:

• Relevant clinical research experience in a pharmaceutical company or CRO
• Individual is proficient with on-site monitoring activities (including pre-study, initiation, routine monitoring and closeout visits)
• Minimum of seven (7) years supervisory experience, including two (2) years of managing managers, in a health care or clinical research setting and minimum of ten (10) years relevant clinical research experience in a pharmaceutical company/CRO
• Thorough knowledge of drug development process
• Thorough knowledge of relevant SOPs, ICH, and GCP guidelines
• Demonstrated ability to lead by example and to encourage team members to seek solutions
• Proven interpersonal skills
• Excellent planning and organisational skills
• Demonstrated ability to successfully manage multiple competing priorities
• Excellent oral, written and presentation skills

Preferred:

• Knowledge of resource management systems
• Demonstrated ability to inspire and drive effective teamwork and influence staff within a matrix system
• Ability to understand and assess technology alternatives and implication for current processes
• Knowledge of Labcorp Drug Development training, human resource and performance appraisal processes and the overall structure of the organisation
• Thorough knowledge of Labcorp Drug Development SOPs

Keywords: Labcorp, Miami , Associate Director, Strategic Partner - Home Based, Other , Miami, Florida