Bioanalytical Principle Investigator-Biomarkers

Description
Bioanalytical Principle Investigator-Biomarkers

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.


Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.


Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.


Discover what your 25,000 future colleagues already know:


Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.


Job Responsibilities

Plan, organize, manage and monitor their work unit's activities according to their field of expertise, the work plan, and the needs of the organization in order to achieve the expected results.

• Collaborate on various critical activities such as workforce planning, hiring, provide input in performance management and daily monitoring of productivity; facilitate knowledge development and ensure the team's efficiency and mobilization.

• Help to develop their work unit's performance indicator systems and the analysis of established objectives. Identify opportunities for improvement. Determine, as needed, the necessary actions to be taken in order to streamline efficiency.

• Monitor and manage budgets of assigned projects and ensure adeherence and complete revenue recgnition. Perform budget follow-up for pertinent stakeholders and recommend actions in an effort to achieve the expected results.

• Communicate the necessary information to ensure colleagues and the organization are aware of their team's work plan, policies, projects, processes, results, and actions.

• Collaboration with partners in the Training team to ensure training is available for team members.

• Represent their work units, both internally and externally, as to consultation and/or information and/or reference.

• Advise internal/external clients of their division's particular areas of expertise by assessing needs, and by carrying out analysis and follow-ups.

• Participate in regulatory agency inspections and client audits as well as the ensuing response process.

• Project manager role:

• Primary client liaison and point of contact for assigned sponsor projects. Receive and distribute information as appropriate from each of these sponsors. Keep the sponsors fully informed of timelines, project milestones and ensure timely communication on bioanalytical studies.

• Support business development activities to grow and maintain new and existing clients.

• Serve as the Principal Investigator for pre-clinical and bioanalytical studies.

• Prepare, revise and/or approve all documentation related to the assigned projects.

• Parnet with Business Development and the Cost Proposal team to prepare various quotes related to service requests made by clients.

• Responsible for the technical and regulatory requirements of the bioanalytical study.

• At times, may direct and participate in the development of new bioanalytical methods. • Provide technical expertise to the laboratory staff.

• Administrative responsibilities including a detailed, accurate short-term forecast of revenue (3 months) and a less detailed long-term forecast (6-9 months) • Daily interaction with the scientific team and management to establish priorities of assignments.

• Result analysis/reporting manager role:

• Review audit reports and observations in order to maintain a high level of quality and consistency.

• Ensure monitoring of corrective actions and preventive actions (CAPA).

• Ensure the smooth functioning and quality of result analysis. • Involve in problem solving and decision-making.

• Involve in bioanalytical report writing and prioritization.

• Ensure compliance and evaluate, identify and communicate the regulatory risks to senior management.

• Participate in the harmonization of work methods between the different divisions/services as well as the different sites.

• Participate in drafting/revising SOPs.

• Optimize and ensure the implementation of their teams working procedures and techniques in order to improve quality.

• Direct and guide archive management within the division.

• Review data and results ahead of client / internal delivery to ensure data is in line with quality expectations.

Additional Qualifications

• Experience in the management of technical and scientific staff.

• Demonstrated leadership, line management, tactical and strategic thinking skills.

• Extensive knowledge of GLP/EMA guidelines and other applicable regulatory requirement.

• Must demonstrate good computer skills especially in the utilization of Microsoft Word and Excel.

• Excellent communications, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.

• Experience within a client-service environment, either in a contract laboratory or within a core group at a pharmaceutical company. • Demonstrate scientific problem solving skills.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:
$79,800.00 - $139,600.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.


Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary
This role is responsible for overseeing biomarker projects from initiation through execution, supporting bid defense activities, and partnering with business development to develop competitive and accurate quotes for new programs.