Independent Committee Project Leader - Adjudication

Great opportunity to join Parexel as an Independent Committee Project Leader (ICPL)!

The ICPL will be responsible for management, general oversight and direction

for IDRA projects, specifically the support and management of Clinical

Adjudication and Data Monitoring Committees. The ICPL will also be

responsible to provide input, advice and direction for project resource planning,

allocation, and CAC and DMC project team management. The ICPL will also

be a point of communication contact and liaison with internal and external stakeholders, strategic planning teams and project review teams including

Quality, financial performance and customer feedback. The ICPL will be

responsible for communication between all members of the project team. If

acting in the PL role, the ICPL will be the single operational point of contact

for this communication. These responsibilities may vary as appropriate,

depending on whether the individual is supporting a DMC or a CAC.

In activities involving project management, the ICPL will be acting as the

functional lead working with the overall Parexel PL (or as the Project

Leader (PL) if the project is a function-led [“standalone”] to ensure that

projects run on time, on budget, and in accordance with client contract, SOPs,

quality standards and regulatory guidelines.

Projects may involve the following tasks:

• Management and support of activities related to Data Monitoring Committee (DMC) oversight. This will also include collaborating with the independent biostatistician supporting the DMC and communication with client, team members, and DMC consultants.

• Management and support of activities related to Clinical Endpoint Committee (CEC) oversight and communication with client, team members, DMC and CAC consultants.

If the ICPL will be acting as the function-led Project Leader (PL) the ICPL will be

responsible for the financial management /administration of the function-led

projects according to Corporate Business Operating Procedures e.g.

• Maintenance of a project plan (Project View or other tool)

• Monthly revenue recognition and forecast activities

• Invoicing according to contract -service and pass through cost (in

cooperation with Project Financial Analyst)

• Monthly control/adjustment of time reported (in TIME)

• Project close out activities WW (in cooperation with Finance Business Partner (FBP))

• Provide project information to Finance Business Partner (FBP)

• Maintenance of Parexel information databases (e.g. GXDB, PIP)

• First point of contact for the client for all financial related issues (e.g. CIS, reminders)

• Coordination/management of project team

In addition, the ICPL will be responsible to provide input, advice and direction

for resource planning and allocation working closely with the global Medical

Services resource planning office, project team management, stakeholder liaison, strategic planning and reviews:

• Management, support, direction, coordination and planning for any DMC or CAC related activities.

• Strategic input, including providing subject matter expertise in the

planning and setup of IDRA projects, including costing, budgeting, resourcing, workflow and process design and analysis.

• Provide training and mentoring to other, less experienced ICPLs and Drug Safety Staff, if applicable.

• Timely contribution to and strategic input and review of proposals (RFP), and contracts as required.

• Liaison with internal (e.g. business operations, account management, Parexel Consulting) and external stakeholders (e.g. clients, third party vendors, health authorities).

• Represent IDRA, if and when required, for internal and external matters.

• Provide support in internal and external audits and inspections and ensure that corrective actions are implemented as appropriate.

• Contribute to IDRA resource planning and strategy.

• Contribute to the costing of IDRA Operations projects, including the review of and improvement of performance metrics and costing tools.

• Attend and lead client meetings and bid-defense meetings.

• Provide timely input and feedback to process improvement.

The ICPL will be required to maintain knowledge of Medical service processes

current as required by regulations and SOPs, and to document competencies

appropriately in the training documentation files.

• Senior ICPLs will mentor and/or line manage ICPLs

• Senior ICPLs will be expected to develop internal and external visibility,

e.g. presentations to internal stakeholders, publications in peer reviewed journals and presentations at conferences.

Skills:

• Excellent knowledge of clinical drug development process

• Operational knowledge of Data Monitoring Committee and/or Clinical Adjudication Committees, including current regulatory guidance

• Experience with computer applications including database management

• Leadership skills – ability to build effective project teams, ability to motivate others, delegation skills, drive and timely/quality decision making

• Personal qualities – ability to gain trust and confidence with a variety of clients as well as within Parexel, good learning ability, managerial courage, action oriented and resilience in a fast-paced and rapidly changing environment

• Business/Operational skills – customer focus, commitment to quality management and problem solving Influencing skills – negotiation and teamwork

• Effective communication skills – provision of timely and accurate information to stakeholders and strong written and oral communication skills

• Knowledge of business operating procedures (e.g. contract approval, revenues recognition, project close out)

• Working knowledge of the Parexel financial and information tools (e.g. PERFORM, Portal, TIME, Impact Harmony, ARGUS, ISIS)

• Basic knowledge of accounting (AP, AR)

• Proficient use of MS Office Suite

Knowledge and Experience:

• Considerable drug safety knowledge and experience

• Substantial experience working in drug development and/or healthcare environment

• Project management and/or significant team leadership experience

Education:

• Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification

• Associates/Diploma degree in any of the above with appropriate work experience

#LI-REMOTE