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66523134 Senior Manager, Clinical Trial Management - Parsippany, NJ

Job Information

ID :
#37972335
# of Positions :
1
Minimum Education Level :
Bachelor's Degree
Experience Required :
7+ years
Duration :
Full Time Regular
Shift :
Unspecified
Hours per week:
40

Job Description

 

About Ferring:By building strong relationships within the scientific community, our medical affairs team has become a trusted partner among patient groups, clinicians and health policy decision makers. We pride ourselves on developing and disseminating information to our key stakeholders so that they can provide the best care for our patients. Because we oversee the entire lifecycle for many of our products, we're on the forefront of developing valuable and scientifically grounded information that will chart exciting paths forward for many of our innovative brands. Join our expert team and drive innovation.Job Description:Contribute to outstanding innovation + Make braver choices
Senior Manager, Clinical Trial Management

Location: Parsippany

As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale while remaining agile and true to our 'people first' philosophy. Built on a 70-year commitment to science and research, Ferring is relentless in pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.

Summary:

Provide oversight and leadership to their clinical operation's direct reports in alignment with the Ferring Philosophy and Leadership Principles. Leader of the Clinical Trial Team, building a strong cross functional team for the execution of a trial or multiple trials and is responsible for the delivery of operational activities as defined in the trial outline/protocol and clinical development plan, to the agreed quality, budget and timelines

Responsibilities:

Operational Excellence:
Provide every day operational management of FIPCUS sponsored and/or local trials.
Work collaboratively with Clinical Operations management team to complete trial planning and resource allocation to ensure shared resources are available across therapeutic areas and groups based on demand and skill needed.
Partner with peers and stakeholders to drive clinical trial excellence. Adopt streamlined processes across groups to leverage operational synergies and provides input to inform continued improvement.

Study Start-Up:
Take responsibility for more complex or novel studies.
Lead or support the development of study protocol and ICF.
Supervise and guide the development, approval, and maintenance of all study plans (i.e. trial risk management plan, communication plan, monitoring plan, data cleaning plan, etc.).
Train and guide others on how to ensure a successful study start-up.
Assist with oversight and development of charters for DMC.

Site Support:
Serve as an escalation point across the clinical operations team for needed site support and questions.
Lead the study team closely during the different phases of the study (Start-up, Maintenance, Closeout).
Conduct routine check-ins, coaching and additional training as needed.
Assess site feasibility (i.e. establish content for questionnaire development).
Take an active role in study startup (i.e. site selection, preparation of site binders and regulatory binders) to ensure all requirements are in place.
Review all trial activity on an ongoing basis to ensure any SOP, competent authority or GCP non-compliance is applied proper CAPA and documentation.
Oversee study conduct (i.e. process study supplies, electronic system access and maintenance (i.e. EDC, IRT, payment vendor, etc.). and study close-out (i.e. track equipment returns).
Act as primary lead for cross functional team meetings through trial start-up, conduct and close-out to ensure activities are in alignment to timelines & budget
Travel to sites as needed to offer additional team support.

Trial Management:
Own alignment of trial deliverables in partnership with leadership and key stakeholders.
Track trial ongoing action items, issues and decisions through the course of the trial. Remove barriers and problem solve as needed to ensure successful trial management and completion.
Present status of trial deliverables to key stakeholders routinely using sound communication and transparency.
Prepare presentations and recruitment graphs required for reportingto key stakeholders.
Oversee and track trial spending in alignment with approved budget.
Own vendor management to participate in vendor selection, RFI, RFP, review and approve invoices, review action items and issue logs, contribute to vendor performance measurement and provide oversight of all trial outsourced activities.
Monitor trial progress in group as well as across clinical operations and own troubleshooting discussions as needed in partnership with management and stakeholders.

Training Materials:
Lead Study Team in Investigator Meeting planning and preparation (i.e., operational presentation oversight of meeting planning vendor, review of presentation, primary point of contact).
Prepare CRA training materials and ensure team alignment.

Quality Data:
Assume an active leadership role in the preparation of data review plan as well as in the EDC and IRT development and UAT.
Work with cross-functional teams collaboratively to ensure quality data and proactively identify areas of improvement.
Contribute to the building and testing of electronic trending tools
Help guide the review and documentation of protocol deviations and perform root cause analysis when applicable.

Laboratory Management:
Lead the selection, set up of labs through study conduct.
Track samples through issue resolution.
Provide sponsor oversight.

Study Team Meeting:
Lead and facilitate the cross functional study team meetings and ensure the documentation and follow-up of action items to resolution.
Participate and prepare presentations for team meetings (i.e. PRM, CDT, GPCT).

People Management:
Provide oversight and leadership to direct reports in alignment with the Ferring Philosophy and Leadership Principles.
Mentor team members by assigning annual SMART goals and individual develop plans that are in alignment to department's performance management goals.
Take accountability for team success and improvement areas to deliver on business goals and objectives.
Manage more senior resources or complex people matters.

Requirements:
BA or BS degree required; Life Sciences or related field preferred.
Minimum 7 years' work experience required; clinical trial experience in pharmaceutical, CRO, or healthcare industry preferred.
Knowledge of GCP/FDA/ICH regulations required.
Thorough knowledge of GCP/FDA/ICH regulations required.
Thorough understanding of clinical research principles and process.
Experience with study start-up, timeline planning and management and financial management of clinical trials including vendor oversight required.
Proficient in MS Excel, Word and PowerPoint.
Experience with data collection processes, data review and comfort with using technology including analytics tools.
Excellent organizational and time-management skills.
Strong interpersonal skills.
Effective verbal and written communication skills including presentation skills.
Team player and able to work independently.
Ability to work well under pressure and with tight schedules.
Ability to identify critical issues and escalation to leadership when appropriate.
Critical thinking and problem-solving mindset.
Strong interpersonal skills.
Works well in a collaborative work environment.
Ability to work well under pressure and tight schedules.
Creativity.
Strong organizational skills are required, as well as the ability to balance changing priorities.
Problem Solving.
Action Oriented.
Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment.
Organizational Agility.

Prospective new hires for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required on your start date unless an exemption has been approved by the Company as a medical or religious accommodation.

Join our team and you'll become part of a close-knit family - one in which you'll be listened to and your contributions valued. Surrounded by like-minded people, you'll have the support to achieve more. So if you love to come up with new ways to make a positive difference and see them through, welcome to the team.

We maintain a drug-free workplace and perform pre-employment substance abuse testing. Location:Parsippany, New Jersey

We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled

Company Information

Name :
Ferring Pharmaceuticals Inc.
Description :
pharmaceutical preparations (except biological) 
Type :
Direct Employer
Address :
100 Interpace Parkway
Parsippany, NJ 07054

Application Information

Online :
Job Posting Entered On :
5/4/2022
Job Posting Expires On :
8/2/2022