Makro Scientific:

Growing Pharmaceutical, Biotechnology and Medical Device companies always need TOP Talent. Since 1996, MakroScientific’s proven staffing solutions have helped many Life Sciences companies succeed and visualize their goals by increasing innovation and decreasing costs while maintaining the complex service level expectations.

Our global presence with offices in USA (NJ, PA, IL, CA) and offices in UK, Europe and Asia enables us to be a powerful contributor and connector of right Talent.

The Clinical Sciences and Operations Senior Project Leader (CSO SR. PL) directs, supervises and manages full Clinical Science & Operations (CSO) platform service projects to the customer’s satisfaction and company success and is accountable for ensuring quality deliverables on time and within budget.

The CSO Sr. PL is expected to be able to effectively lead large complicated program development and/or multiple programs simultaneously with minimal guidance.

The Sr. CSO PL is the main partner and interlocutor for the platform with its customers’ and the teams within the platform.

The CSO SR. PL is accountable for ensuring the deliverables via effective account, program, project management and leadership skills in a manner that will optimize, integrate and utilize CSO resources and competencies.

The CSO SR. PL will provide operational input into the clinical strategy by providing CSO expertise to development or medical affairs plans and presenting the best operational strategy for the successful conduct of the project.

The CSO SR. PL contributes to the definition of the outsourcing strategy for the project.

Ensures reliable performance and productivity by leading and coordinating all platform expertise and services for the allocated project(s) / program(s) and is accountable to both the customer and platform for project deliverables, including the timelines, quality and budget.

The CSO SR. PL is also the CSO’s main interface with other platforms, units for the project and enabling functions.

The CSO Sr. PL is expected to mentor others and contributes to process improvement efforts and drives operational process implementation and compliance.

JOB SUMMARY: Briefly summarize the primary purpose or function of the job (why does it exist?) The Clinical Sciences and Operations Senior Project Leader (CSO SR. PL) directs, supervises and manages full Clinical Science & Operations (CSO) platform service projects to the customer’s satisfaction and company success and is accountable for ensuring quality deliverables on time and within budget.

The CSO Sr. PL is expected to be able to effectively lead large complicated program development and/or multiple programs simultaneously with minimal guidance.

The Sr. CSO PL is the main partner and interlocutor for the platform with its customers’ and the teams within the platform.

The CSO SR. PL is accountable for ensuring the deliverables via effective account, program, project management and leadership skills in a manner that will optimize, integrate and utilize CSO resources and competencies.

The CSO SR. PL will provide operational input into the clinical strategy by providing CSO expertise to development or medical affairs plans and presenting the best operational strategy for the successful conduct of the project.

The CSO SR. PL contributes to the definition of the outsourcing strategy for the project. Ensures reliable performance and productivity by leading and coordinating all platform expertise and services for the allocated project(s) / program(s) and is accountable to both the customer and platform for project deliverables, including the timelines, quality and budget.

The CSO SR. PL is also the CSO’s main interface with other platforms, units for the project and enabling functions.

The CSO Sr. PL is expected to mentor others and contributes to process improvement efforts and drives operational process implementation and compliance.

Knowledge And Skills:

Strong project management experience, transversal and strategic leadership capabilities, communicatation skills and a business acumen are required. Ability to drive for a high performance cross functional team that empowers and motivates individual members and the team as a whole.

Strong interpersonal skills required to effectively collaborate with customers (physicians, scientists and managers from various disciplines) and set and manage expectations clearly. Proactively ensures targets and milestones are met; captilizes on opportunites to exceed expectations.

Serves as internal consultant and primary liaison with all groups outside of the CSO platform for projects. Able to build credible services/deliverables for both the CSO and its customers.

Project Management Skills

Business acumen

Excellent organizational, interpersonal and communication skills (verbal & written) Customer and quality focused

Capability to effectively handle large complicated global projects that integrates various discliplines.

Proactive

Ability to drive decision making process

Innovative problem solving

People, Change and Influence management skills

Ability to set and manage expectations

Ability to effectively mentor others

Strong leadership abilities Ability to deliver clear and concise messages. Self-motivation, results driven, detail-oriented and good organizational skills§

Abilty to resolve conflict

Strong negotiation skills

Culturally sensitive

Familiarity with computer software

Formal Education And Experience Required:

US: Bachelor’s degree (advanced degree preferred) and 15+ years of laboratory and/or medical experience or research experience in the pharmaceutical industry (or equivalent) is required.

****10 years of project management or international clinical study management experience is required.

****: Scientific medical degree (MD, PhD, PharmD) or basic science background (e.g. Engineer) and a minimum 10 years of experience in clinical research in pharma industry/CRO, with strong expertise in project management in an international context.

Sound experience in people management as well as experience in pharma/CRO business a plus.

CN: At least Master degree in relevant scientific and/or medical field and a minimum of 8 years experience in clinical research in pharmaceutical industry. Profound project management experience is required. People management experience is a plus.

Major Duties & Responsibilities

CSO’s primary contact with its customers for assigned project/programs.

Ensures appropriate communications channels are maintained and reporting schedules adhered to. Key relationship manager for the program.

Responsible for providing input into the operational strategy and accountable for adapting operational plans, with input from all applicable functions within the CSO, in order to propose the optimal clinical operations solutions and scopes of work that creates the most value for the project, customer and the platform.

Builds a strong relationship with the customer based on performance in order to build a credible service within the platform and for the customer.

Develops and negotiates study/program budgets, timelines and other expectations in order to establish clear expectations.

Accountable for financial oversight of the project/program.

Re-negotiates when required.

Responsible for routine reporting of the project’s status to the customer

Responsible for assessing the impact of the project for the platform

Assesses the impact of the project on the platform Accountable for ensuring the study/program performance within the CSO and for driving the multi-disciplinary CSO project team according to project requirements & defined project objectives in order to create the most value for the project.

Transmits clear project requirements to the CSO functions.

In conjunction with the function leads within the CSO, builds study teams that are adapted to meet the customer’s needs/requirements.

Sets team goals and provides performance reviews for the team performance.

Lead CSO Operational Project Team meetings to address status (operational, budget & resource) and critical issues.

Foster a true, business minded, customer-oriented atmosphere and skill set for the project team allocated across functions.

Develop and implement continuous improvement for assigned projects to ensure the quality of the deliverables.

Oversight and accountable for project performance to ensure it meets the customer’s and CSO’s expectations as far as timelines, quality and budget. Makes adjustments to the project and/or team as required in order to establish a credible service for the customer.

Anticipates project risks and develop and implement risk management plans to minimize negative impact in fulfilling project deliverables.

Lead development of phase transition plans for project.

Supervise maintenance of the project management information and tracking. Represents CSO when collaborating and goal setting with other platforms and enabling functions in order to successful meet the requirements of common customer(s).

Lead the discussion on the choice of vendors for outsourced programs and providing input into vendors used for specific activities and is accountable for deliverables for full-package outsourcing.

Contribute to CSO business expansion and to develop the CSO catalogue for services

Identify opportunities for improving organizational processes to continue to drive organizational excellence.

Mentors others CSO Project Leaders.

******

Major Challenges/Problems:

List challenges or problems commonly encountered in this job, how they are solved, and with whom they would typically be solved.

Understanding and contributing to the customer’s overall strategy. The CSO SR.

PL should be recognized as a major contributor for the customer’s operational strategy and drives the strategy in a manner that simplifies and improves the cost effectiveness of the program.

The CSO SR. PL then builds the operational strategy and implements this strategy within the CSO, ensuring the operational performance meets the expectations of the customer while building value for the platform.

The CSO SR. PL, with collaboration with the Management Office and leaders of the functions within the CSO, will need to establish with the customer mutually agreeable project expectations, deliverables and a budget.

The CSO SR. PL, in collaboration with other function leaders, will need to create teams adapted to the customer’s requirements and within the defined budget.

The CSO SR. PL will then need to ensure the project performance meets expectations by continually monitoring project progress, anticipating risks/issues, devising strategies to mitigate risks and adapting plans as necessary to address the issues in a proactive manner.

The CSO SR. PL will need to establish team leadership/essential customer expectations within the CSO and provide feedback on the CSO project team’s performance.

CSO SR. PL ensures customer expectations are met while maintaining CSO Sr. PLatform cohesion

Key Internal and External Relationships – Frequent basis: Customer’s from other units, project/study team members and function leads/heads, when required, within the CSO.

As required: other platform and enabling groups. Outside vendors and other outside organization that could assist increasing project performance. External clients.

Decision Making Authority: Identify the types of decisions made by this job as well as those that must be referred to a superior (i.e., authority to implement plans, personnel decisions, changes to policy, etc.)