Senior CDS Project Manager

Description

Senior CDS Project Manager

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

JOB SUMMARY

Ensures the contracted services and expectations of a clinical project are carried out by the Company project team in accordance with the executed contract and the Customer’s expectations. Works in the role of a project manager on assigned project(s), which may range from single CDS projects to large full scope CDS projects. Duties include primary liaison with Customers, Clinical team, Vendors, Functional leads, and Senior Management. Acts as a mentor to other CDS (Clinical Development Services) Project Managers.

• Note CDS (Clinical Development Services) may also be known as ‘Biometrics’ (i.e. Data Management, Statistics, Statistical Programming, and Medical Writing)

JOB RESPONSIBILITIES

• Acts as a primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and Company’s contractual agreement. Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations.

• Serves as the team leader by overseeing the Biometrics project team. Facilitates team building and communication. Acts as a liaison and facilitator between other departments within the Company for project related tasks and/or issues. Proactively monitors project resources and works with functional lead/management to ensure project requirements are met.

• Manages multiple projects ranging in size and complexity from single service Biometrics projects to large full scope Biometrics projects, global projects and/or programs, with minimal interaction from supervisor. This includes proactive operational and financial management of tasks, risk, escalations and quality through start-up through final deliverable.

• Manages the executed contract and financial aspects of assigned projects/programs. Completes periodic review of tasks completed and backlog. Ensures customers are notified of out-of-scope items in a timely manner.

• Works with internal teams like finance, accounts, contracts to ensure effective financial, contractual and invoice management and issue resolution.

• Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports, and ensures adequate documentation of each communication.

• Independently prepares information for internal review meetings and proactively manages action resolution to ensure project delivery

• Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status and tracking reports as well as functional area plan, to appropriate team members and senior management.

• Networks to acquire new and/or repeat business.

• Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities as needed. Works with this team and department leads to develop budgets and scope of work for the final contract as needed.

• Initiates or collaborates with internal teams/clients on process improvements, new processes or any specific initiatives as needed.

QUALIFICATION REQUIREMENTS

• BA/BS in life sciences, communications, nursing, or equivalent related education and experience.

• 7 to 8+ years of Industry experience (preferably from PM in clinical data science/Biometrics background), able to handle independently.

• Preferrable to have experience in leading projects & deliverables across function CDM, MW, Biostats, Stats Prog, etc.

• Responsible for managing project finances (Budget, Revenue Recognition), Contracts, Invoicing, Timeline planning (e.g. Microsoft Project), Risk assessment.

• Leading a Biometrics/Clinical Data Science Project team and liaising with Clinical Team, Vendors & Clients.

• Project management experience in a contract research organization, pharmaceutical, or Biotechnology Company preferred.

• Experience actively managing clinical research projects across CDS functional areas.

• Previous CRO experience and specific CDS management experience.

• Other relevant experience preferred.

• Thorough knowledge of major HA (e.g. FDA, EMEA, PMDA) regulations, drug development, and project management procedures.

• Demonstrated proficiency with ICH/GCP guidelines.

• Excellent communication skills.

• Strong presentation, documentation, and interpersonal (emphasis on proactive leadership) skills as well as a team-oriented approach.

• Proficient computer skills in Word, Excel, PowerPoint, MS Project, email and internet.

• Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.

• High level of competence in English language.

• Ability to travel up to 25%.

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.

http://www.syneoshealth.com

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

Ensures the contracted services and expectations of a clinical project are carried out by the Company project team in accordance with the executed contract and the Customer’s expectations. Works in the role of a project manager on assigned project(s), which may range from single CDS projects to large full scope CDS projects. Duties include primary liaison with Customers, Clinical team, Vendors, Functional leads, and Senior Management. Acts as a mentor to other CDS Project Managers.* Note CDS may also be known as ‘Biometrics’ (i.e. Data Management, Statistics, Statistical Programming, and Medical Writing)