Associate Director, Integrated Trial Solutions (Hybrid-Quincy, MA)

Elligo Health Research
Quincy, MA Full Time
POSTED ON 4/24/2024

I. JOB SUMMARY

The Associate Director will serve as one of the key managers of the Patient Services division of Elligo Health Research. This role will be responsible for operational planning, KPI management, team collaboration, team communications, and system rollouts as needed. Integrated Trial Solutions department will include any trial related services, e.g.: “Integrated” site model, Decentralized Trials- Home Health Care Program, Staffing service line, Data Management Services- remote based monitoring and centralized eSource programs. The Associate Director will be a key member of the leadership team, driving crisp and objective decision-making, determining appropriate resource allocation, helping implement new strategies around business acceleration and steering critical objectives toward transformation and innovation.

The Associate Director will be responsible for, sustaining growth and providing great customer service to our clients. This position has colleagues that directly report to them.

To perform this job satisfactorily, an individual must be able to perform each essential duty satisfactorily.  Other duties may be assigned.

II. SUPERVISORY RESPONSIBLITIES

 
  • Leads internal team members to ensure integrated project milestones are met as contracted.
  • Oversees and delegates tasks to appropriate team members based on project deliverables and team member utilization/allocation.
  • Coordinates an internal “kick-off” meeting to review project delegations and expectations for any new projects.
  • Creates, reviews, and trains all internal team members on each Project Plan, as well as any SOPs and Guidance Documents that pertain to each team member’s role and responsibilities.
  • Ensures all team members acknowledge and understand their assigned duties and tasks. As tactics are revised and change orders are implemented, PM will work with each team member to alter Project Plans and timelines to ensure strategy alignment.
  • Responsible for organizing and leading weekly meetings with the internal team to review project deliverables and expectations as well as plan and re-strategize as needed.
  • Corresponds with and manages vendors for projects, as applicable based on deliverables.
  • Monitors and verifies team member time entry on assigned projects.
  • Hire, train, and manage a team of project managers and marketing coordinators.
  • Manages and coaches’ employees by hosting weekly 1o1 meetings for each team member, ensuring that agendas, minutes, and action items are completed and that appropriate reports are delivered to department VP.
  • Supervises assigned direct reports (number of direct reports may vary over time).
  • Conducts and manages employee reviews.
  • Manages HR-related issues that may arise.
  • Manages time off reviews and approvals.
  • Ensures compliance with all company SOPs, departmental Guidance Documents, and company policies.

III. ESSENTIAL DUTIES
 
  • Serves as the escalation point for clients and internal team related to projects being managed by a Project Manager or Senior Project Manager.
  • Supports and guides the Project Manager to successful execution of projects by providing consultation when needed.
  • Attends ITS project client calls, as needed, to be able to provide excellent levels of oversight.
  • Coaches Project Managers to grow and develop as project managers and client advocates.
  • Understands each protocol assigned, in collaboration with all team members across departments.
  • Initiates a proactive approach to strategy adjustment when existing strategies are losing momentum and client satisfaction is not high.
  • When needed, inserts oneself into the project to identify potential improvements and guide the project manager to implement those improvements.
  • Reviews and approves invoices based on validated time entry by team and strategy for scope implementation.
  • Ensures revenue is realized and projects function within budgetary parameters for each project/program assigned.
  • Analyzes study weekly reports and projections and implements changes to strategy/tactics as necessary to achieve contracted goals.
  • Leads the development of project turnaround strategies when initial approaches are not working.
  • Provides feedback to Management regarding the maintenance of effective levels of recruitment activities for each project.
  • Provides customer training on the patient tracking software that is hosted in Salesforce.
  • Responsible for tracking projects budgets and working with Business Development to execute change orders.
  • Ensures client complaints and CAPAs are documented in a timely manner in collaboration with the Compliance team.
  • Responsible for all project setup tasks for all applicable technology platforms.
  • Responsible for ensuring all project management related tracking mechanisms are updated daily/weekly as applicable.
  • Responsible for leading client meetings which may include discussions related to contract deliverables, budget allocation, performance metrics, projection modeling, and site performance.
  • Serves as an extension of the client team to spearhead this understanding and tactic completion.
  • Compiles weekly or monthly reports (based on client’s needs) for all projects.

IV. KNOWLEDGE SKILLS AND ABILITIES REQUIRED
 
  • Minimum of 5 years of clinical research project managing/leading experience
  • BS/BA in Life Science or related discipline is a plus
  • Current on FDA regulatory regulations, and guidance to date
  • Working knowledge of clinical research methodology, protocol and study design, and IRB-approval processes.
  • Thorough understanding of utilization tracking and maximization as well as KPI achievement and adjustment.
  • Comfortable in a results-driven, revenue-focused atmosphere that rewards individuals based on merit and performance
  • Demonstrated ability in positive relationship building, with strong verbal and written skills required
  • Strong organization/prioritization skills for the management of multiple concurrent projects
  • Ability to work well under timelines and deliverable targets
  • Strong interpersonal skills with attention to detail a must
  • Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems
  • Ability to travel for Clinic activities, QC visits, training, company meetings, etc.

V. WORKING CONDITIONS

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.

Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.

Minimal (less than 10%) travel is required for this position.

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position.  They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel.  More in-depth information can be found in SOP's, working guidelines, policies, etc.

Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.


 

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