Clinical Study Manager, Oncology

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.

Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for rare diseases, focusing on providing treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, better diagnoses, and improved treatment access in endocrinology, metabolic, hematology and oncology franchises. RRD is dedicated to fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.

Reporting Structure

Reports To: Senior Director of Evidence Generation, North America
Direct Reports: N/A
Areas Managed: Clinical Studies

Overview

The Clinical Study Manager will support clinical research activities as well as any medical activities related to post-marketing regulatory commitments in the US, and Investigator Sponsored Studies.   This person helps in the realization of the clinical development programs and is responsible for the delivery of multiple clinical studies from the study concept through submission.  The CSM will also support Global Clinical Operations activities and initiatives as needed. 

Essential Duties and Responsibilities

The Clinical Study Manager leads the study and/or study team members and manages study deliverables in alignment with the study timelines and is the primary contact and interface between the functional groups involved in each study project.
•    Plan, manage and ensure execution of US studies as part of a clinical development phase, post-marketing regulatory commitments and IIS trials from study concept through study completion. Responsible for achieving time, cost, quality goals and milestones
•    Provide input for the clinical sections of clinical study protocols, informed consents, clinical study report, where applicable
•    Participates in and supports the selection of CROs for each study.
•    For assigned studies, manage the CRO throughout the trial (regular meetings, timeline adherence, monitoring enrollment progress, TMF checks, etc.)
•    Participate in Standard Operating Procedures writing and review process related to clinical activities
•    Managing issues and problem solving and communicate clearly and regularly with management and escalate appropriately
•    Ensure regulatory compliance, ICH and GCP adherence
•    Experience with electronic CTMS, eTMF, IVRS, EDC systems (Veeva and Medidata RAVE systems are a plus)
•    Facilitate the Confidentiality Disclosure Agreements and contract negotiations with sites, vendors where applicable.
•    Participate in the reconciliation process with Pharmacovigilance department and Data Management department
•    Collaborate with MSL colleagues to ensure all Investigator sponsored studies are performed according to legal/regulatory guidelines.

Education and Experience

•    Bachelor’s degree required, preferably in the life/physical sciences and adequate work experience in relevant field of clinical research activities.
•    Strong scientific background with relevant of clinical development experience in managing clinical studies and working in matrixed teams.
•    Clinical development and pharmaceutical experience with a good knowledge of the applicable regulations in order to have a thorough understanding of the processes associated with executing clinical development plans.

•    Oncology experience strongly preferred
•    Experience supporting regulatory submissions highly desired.

Knowledge and Skills

•    Have exhibited leadership, able to work in matrixed teams
•    Fluent in English (oral and writing)
•    Capacity to manage multiple projects

•    Initiatives and self-motivation abilities
•    Flexible and adaptable
•    Well organized
•    Positive thinking and enthusiasm
•    Able to work in a small –middle size company
•    Project management experience
•    Experience with rare diseases a plus 
•    Excellent time management and ability to work independently
•    Familiarity with FDA approval procedures
•    Excellent computer skills. Strong proficiency in Microsoft programs: Excel, Word, PowerPoint, Access including ability to run analyses using pivot tables
•    Knowledge  of SAP is a plus
•    Extensive knowledge of cGMP regulations, ICH Guidelines, and CMC (Chemistry and Manufacturing Controls)
•    Quality mindset related to execution of clinical studies and ALCOA+ principles.
•    Solid understanding of the principles of negotiation, influence and conflict management to assure effective interactions within and across departments.
•    Demonstrated ability to manage multiple competing priorities.

Competencies and Attributes

•    Behaves in an honest, fair and ethical manner.
•    Pursues self-development.
•    Communicates in a clear, concise and convincing manner.  Listens effectively.
•    May be called on to assist in developing new members of the company.
•    Responsible for tactical implementation of pre-defined programs and projects.
•    Solves issues of moderate complexity.
•    Works independently on issues where analysis of situation or data requires evaluation of different factors.
•    Monitors expenditures.
•    Goal-oriented, with ability to plan for the long-term and execute.
•    Innovative and driven, with a “can do” mindset.
•    Excellent organizational skills and the proven ability to manage multiple priorities simultaneously.
•    Ability to achieve influence without authority and communicate effectively with all layers of Management.
•    Ability to liaise cross-functionally and build consensus. 
•    Demonstrated ability to maintain a professional demeanor at all times.
•    Keen attention to detail.
•    Sound judgment.
•    Strong relationship-building skills. 
•    Experience executing within regulatory framework (FDA, DEA, Health Canada guidelines). 
•    Strong presentation, planning/organization and decision-making skills.
•    Strong analytical and problem-solving skills.
•    High level of initiative and commitment; strong work ethic.
•    Solutions-oriented mindset; commitment to continuous improvement.
•    Ability to see the broad picture while executing on details.

•    Resourcefulness; ability to make things happen within a small-business environment.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.  Based upon job requirements, employee may be required at times to attend meetings including travel out of state over weekends and nights.  Employee must be able to freely operate and travel by car and train/plane modes of transportation.  Employee is required to have a valid driver’s license and means of transportation.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be able to fly via commercial air carrier.  
This is largely a sedentary role; however the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear. Occasionally is required to lift and/or move light to moderate weight up to 25 lbs.

Location/Travel

•    Onsite: Bridgewater, New Jersey office. 
•    The position requires domestic travel (up to 50%); occasional international travel.

FLSA Classification

•    This position is considered Exempt.

EEO Statement

It is the policy of Recordati Rare Diseases to provide equal employment opportunity (EEO) to all persons regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin.  Further, Recordati Rare Diseases will not discriminate on the basis of any characteristic protected by federal, state, or local law.  Recordati Rare Diseases will provide reasonable accommodate for qualified individual with disabilities.  

Disclaimer

This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.