Senior Project Lead

Job Purpose:

The Senior Safety Services Project Leader (SSSPL) will provide leadership, management, general oversight, and direction for Medical Services projects, including but not limited to medical monitoring, clinical and post -marketing pharmacovigilance. The SSSPL will also be responsible to ensure client satisfaction, project team management and communication, quality, adequate resource planning and allocation, and financial performance related to safety services. Depending on the project, the SSPL may serve as a Functional Leader on a full-service project or a Project Leader on standalone project. When serving as the functional lead, the SSPL will serve as the primary point of contact and communication between the Parexel Project Leader, the Sponsor team and Medical Services worldwide and, with the Global Lead Physician (GLP) be accountable for performance of the entire Medical Services team on that project. The SSSPL acts as a role model and/or mentor for the team and SSPLs. SSSPLs may support additional management responsibilities if requested.

Key Accountabilities:

Depending on the project, the SSSPL may serve as a Functional Leader on a full-service project or a Project Leader on standalone project.

When serving as the Functional Leader, the SSSPL will provide leadership, management, general oversight, and direction for Medical Safety Services projects, including but not limited to medical monitoring, clinical and post - marketing pharmacovigilance. The SSSPL will also be responsible to ensure client satisfaction, project team management and communication, quality, adequate resource planning and allocation, and financial performance. The SSPL will serve as the primary point of contact and communication between the Parexel Project Leader, the Sponsor team and Medical Services worldwide and, with the Global Lead Physician (GLP) be accountable for performance of the entire Medical Services team on that project. As a Functional Leader, the SSSPL will be responsible for management, general oversight and direction for Medical Services projects, including medical monitoring, clinical endpoint and data monitoring and review, and clinical and post - marketing Pharmacovigilance (PV) projects. The SSSPL will also be responsible to provide input, advice and direction for project resource planning and allocation, and overall Medical Services project team management, The SSSPL 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 SSSPL will be responsible for consistent and complete communication between all members of the Worldwide.

In addition, the SSSPL 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 medical and other pharmacogilance (PV) related activities,

• including oversight of and contribution to PV consulting

• projects.

• Strategic input, including providing subject matter expertise in the planning and setup of PV projects, including costing, budgeting, resourcing, workflow and process design and analysis.

• Provide training and mentoring to other, less experienced SSSPLs and Safety Operations Staff.

• 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 Medical 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 Medical and PV Operations resource planning and strategy.

• Contribute to the costing of Medical and PV 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.

• SSSPLs will mentor and/or line manage SSPLs

• SSSPLs will be expected to develop internal and external visibility, e.g. review SOPs, engage in initiatives, prepare presentations to internal stakeholders, publications in peer reviewed journals and presentations at conferences. When serving as the Project Leader on standalone projects, the SSSPL is independently responsible for all Project Leader tasks and deliverables according to SOPs on assigned projects including:

• Attend and lead Bid Defense Meetings along with the Business Development team

• Develop and maintain a formal project plan with all key milestones, budgets, and resources assigned to specific tasks and outcomes. Define metrics for reporting performance against plan.

• Ensure that all standard project systems and tools are set up correctly and functioning appropriately.

• Implement operational strategy as defined in the project plan and makes changes to the plan to ensure desired results. Proactively solve problems in collaboration with the client and project team. Seek advice or approval from PD or PFD or equivalent as and when required.

• Close out of all project activities upon project completion; perform financial reconciliation and system closeout. Identify best practices developed during project and share lessons learned across the organization. In this capacity the SSSPL 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 Analyst)

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

• Project close out activities WW (in cooperation with Project Analyst)

• Provide project information to Project Analysts

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

• Coordination/management of project team In activities involving project management, the SSPL will be acting as the Medical functional lead working with the overall Parexel PL or as the Project Leader (PL) if a the project is a function-led Medical project, 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

• Clinical trial safety management – receipt, processing, data-basing, follow- up and regulatory reporting of SAEs.

• Clinical trial medical monitoring – review of endpoints, lab alerts and waivers.

• Clinical trial cumulative and/or per-patient data review

• Post-marketing PV - receipt, processing, data-basing, follow-up and regulatory reporting of spontaneous adverse drug reactions (ADRs), author and review project specific standard operating procedures related to ICSR management, conduct and review of literature searches, signal management, preparation and submission of PSUR/DSURs.

• Any other activities as required by lifecycle drug safety services. The SSSPL will be required to maintain PV knowledge and knowledge of any other Medical service processes current as required by regulations and SOPs, and to document competencies appropriately in the training documentation files.

• The SSSPL will be the single operational point of contact in Medical/Safety Services for this communication.

Skills:

• Excellent knowledge of drug safety and the drug development process

• Excellent knowledge of and ability to interpret and apply global safety and other relevant regulations

• Experience in evaluation of safety data and the preparation of safety reports

• Experience with computer applications including database management and pharmacovigilance related computing systems

• 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 fastpaced 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)

• Basis knowledge of accounting (AP, AR)

• Ability to create a sense of urgency and take a proactive, solutions-based approach • Budget management skills

• Client focus

• A flexible attitude with respect to assignments and new learning

• Ability to prioritize and manage multiple, varied tasks with enthusiasm and attention to detail

• Ability to thrive in a matrix environment and to value the importance of teamwork

• Basic understanding of all aspects of project life cycle • Ability to work independently with oversight guidance

• ICH and GCP regulations in relevant geographies

• Solid clinical knowledge and basic understanding of clinical research

• Proficient use of MS Office Suite and project planning software

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

• Strong command of written and spoken English language, local language proficiency as required

• Proven track record of developing client relationships at project level

Education:

• Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification, or relevant work experience in Pharmacovigilance.

• PMP or equivalent preferred