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Global Study Manager (GSM) for our Indianapolis, IN Location – U.S Remote Based Positions are Available
The Company – COVANCE
As one of the world’s largest and most comprehensive drug development services companies, Covance has helped pharmaceutical and biotech companies develop one-third of the all prescription drugs in the marketplace today.
The Position
The Global Study Manager must prove to be knowledgeable and experienced in project management techniques related to clinical trials. The Global Study Manager is responsible for key client deliverables including budget, risk, and milestone management. Global Study Managers must demonstrate leadership across the Covance study team, keeping a collaborative attitude and fostering excellent communication within the team. Global Study Manager must be able to combine a strong understanding of client protocol specifics and study feasibility, to ensure successful study management and provision of outstanding customer service.
Responsibilities/Duties:
- Key contact for clients; Liaison between Clients, CRO, and Covance
- Displays leadership to ensure successful interactions between Covance study team members needed to provide seamless study delivery to the client.
- Provides project management oversight; focusing on key client deliverables through budget, risk, and milestone management.
- Facilitates communications between Client and extended Covance study team, including Study Design Lead and Regional Study Coordinator.
- Performs review of SOW to ensure quality implementation of client specifics and requirements.
- Manages a portfolio of global and local studies with varying complexity.
- Acts as an ambassador on behalf of the client within Covance CLS and across Covance business units; exemplifies the concept of Signature Client Service through outstanding, personalized customer service skills
- Ensures that all customer expectations are documented and acted upon in compliance with regulatory requirements
- Demonstrates through appropriate self-organization the ability to manage conflicting priorities and to make difficult decisions
- Able to act efficiently in an environment with dynamic timelines and priorities
- Accountable for the implementation, monitoring and reporting of performance metrics
- Actively participates in Covance CLS development through continuous process improvement, quality and productivity
- Work with appropriate internal and external personnel to understand the culture and pipeline of assigned clients
- Demonstrates strong interpersonal and communication skills that will build strong internal and external relationships to ensure deliverables are on time and within budget
- Displays appropriate self-organization and ability to manage conflicting priorities
- Participate in functional meetings (eg. CLFs) and provide input, keeping processes up to date
- Comply with CCLS Global Project Management strategy
- Support a culture of continuous improvement, quality and productivity
- Other duties as assigned
Education/Qualifications
- High School Diploma required
- University degree in a scientific field strongly preferred
Experience
- 2 years related industry experience; project management experience in clinical trials would be a strong asset.
Position Summary
- Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
- Provides operational input into protocol development
- Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
- Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
- Ensures compliance with the clinical trial registry requirements
- Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
- Provides input into baseline budget development and management
- Provides input into baseline timeline development and management
- Leads risk assessment and identifies risk mitigation strategies at the study level
- Leads the feasibility assessment to select relevant regions and countries for the study
- Oversees/conducts site evaluation and selection
- Leads investigator meeting preparation and execution
- Monitors progress for site activation and monitoring visits and acts on any deviations from plan
- Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan
- Monitors data entry and query resolution and acts on any deviations from agreed metrics
- Ensures accurate budget management and scope changes for internal and external studies
- Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
- Escalates issues related to study conduct, quality, timelines or budget to Program Operations Lead (POL) and other stakeholders and develops and implements appropriate actions to address issues
- Oversees the execution of the clinical study against planned timelines, deliverables and budget
- Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
- Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
- Ensure clinical project audit and inspection readiness through the study lifecycle
- Supports internal audit and external inspection activities and contributes to CAPAs as required
- Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
- Contributes to clinical study report writing and review
- Facilitates and contributes to study level lessons learned
- Assigns tasks to Clinical Study Management staff and supports their deliverables
- Recommends and participates in cross-functional and departmental process improvement initiatives
- Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs
- Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight
- May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring
Requirements:
- Demonstrated interpersonal & leadership skills
- Ability to understand and implement the strategic direction and guidance for respective clinical studies
- A data driven approach to planning, executing, and problem solving
- Effective communication skills via verbal, written and presentation abilities
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
- Ability to influence and negotiate
- Budget management experience
- An awareness of relevant industry trends
- Ability to build productive teams and collaborations
- Demonstrated vendor management experience
- Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
- Experience in global clinical trial operations including experience developing protocols and key study documents
- Knowledge of ICH/GCP and regulatory guidelines/directives
- Effective project management skills, cross-functional team leadership and organizational skills
- Line management experience preferred
Bachelor’s degree and minimum of 6 years relevant industry experience; advanced degrees may be considered in lieu of relevant experience.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Biotrial, a leading provider of high-quality pharmacology services, is currently recruiting a Clinical Study Project Manager to join its team in theU.S. headquarters in Newark, New Jersey. With over 25 years of experience in providing scientific and medical services in Early Clinical Development, Biotrial possesses one of the largest clinical capacities in Europe. The company’s 60,000 sq. ft., 110-bed, state-of-the art Clinical Pharmacology Unit is in the heart of University Heights Science Park, attached to Rutgers/NJMS and the University Hospital.
As a Clinical Study Project Manager,you will provide customer-focused leadership and project oversight. In this position, you will facilitate communication among team members, including study monitors, sponsor personnel and the Biotrial Project Team. You will have responsibility for proactively solving issues, and overseeing the successful implementation and monitoring of clinical studies to ensure that studies are conducted in accordance with ICH/GCP and applicable regulations. You will work in our state-of-the-art Clinical Pharmacology facility in Newark.
Responsibilities:
As a Clinical Study Project Manager, you will manage Clinical Research studies including but not limited to:
- Managing and coordinating the activities of clinical trials with the Biotrial Project Team.
- Serving as the main point of contact with sponsors regarding project timelines, updates, needs and emerging issues.
- Developing study timelines based on protocols.
- Ensuring project start-up activities by facilitating processes for the preparation of regulatory documents, ensuring timely IRB approvals for clinical trials.
- Leading the internal project meetings including Kick-off meetings and Study Initiation meetings, etc. with sponsors/internal teams.
- Following screening and recruitment activities to ensure timely enrollment in the studies.
- Organizing Safety Review Meetings with the principal investigator / sub-investigator / medical and scientific affair team members.
- Monitoring project scope and ensuring deliverables are fulfilled within timelines and budget.
- Supporting the Biometrics team to ensure completion of Clinical Study Reports.
- Managing study contracts/budgets, including approval of vendor/site contracts, budgets and invoices. Collaborating with the Accounting Department to ensure billing agrees with pre-established milestones.
- Ensuring timely interaction with management, sponsors, and/or functional team members on matters concerning resource allocation, project milestones, regulatory issues, and other relevant issues.
- Organizing sponsors’ visit of the Unit (Site qualification visits, Initiation Meetings, Monitoring visits and Close-out visits).
Requirements:
- Requires a Bachelor’s degree (Masters a plus) in life sciences or related field.
- Minimum 3-5 years of experience in Phase 1 clinical research and knowledge of GCP and FDA regulatory requirements is required.
- Good understanding of the drug development process.
- Must have previous experience managing projects and in monitoring clinical studies.
- Excellent written and verbal communication skills, as well as interpersonal skills.
- Exceptional time management and conflict resolution skills required.
- Ability to interact with all levels of management, sponsor and study site personnel.
- Detail-oriented and possess good trouble-shooting skills with the ability to prioritize and execute tasks in a high-pressure environment.
- CCRC certification preferred.
- Proficient computer skills in Microsoft Office Suite.
- Occasional travel may be required for bid defense, initiation or kick-off meetings, or other study-related activities.
Biotrial is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, genetics, disability, age, veteran status, or any other characteristic protected by law.
Job Type: Full-time
Experience:
- Phase 1 Clinical Studies: 3 years (Preferred)
- GCP and FDA Regulations: 1 year (Preferred)
- Clinical Trials: 3 years (Required)
- Clinical Research: 3 years (Preferred)