Study Management Manager

Biosimilars – Manager Study Management (Biosimilars – MSM)

Purpose :

Primary point of contact to lead, manage, and coordinate, in partnership with the Contract Research Organization (CRO), the conduct of clinical trials from study design to close out at a global level in accordance with ICH-GCP

Oversee the quality and scientific integrity of clinical operations for studies at a global level

Collaborates with cross-functional stakeholders to ensure timely and on-budget execution of clinical trial deliverables Responsible for :

Global biosimilar development operational execution through oversight of cross-functional trial activities in partnership with CRO

Ensuring implementation of trial(s) in partnership with CRO in accordance with applicable SOPs and ICH / GCP guidelines

Execution of clinical studies with high quality, on time, and within budget

Contribute to the authoring and review of key study documents

Day-to-day management of study execution including management of study timelines

Managing program-level operational issues and oversight of study team issue escalation

Supports / Leads the Global Clinical Study Team for the allocated program(s)

Communicating global status of clinical study programs to senior management

Contributing to initiatives and process improvement work streams, including process mapping of CROs

Leads or supports the execution of all studies for a biosimilar program. Includes, but not limited to, PK / PD studies, global pivotal studies, chart reviews, region-specific studies, and device studies as appropriate

Oversee the development of study timelines and budgets for studies within a biosimilar program

Leads or co-leads (with Clinical Data Management) a cross-functional team to review clinical study data to ensure high-quality deliverables from the CRO

Review and contribute to the creation of study documents, eg, synopsis, protocols, study plans, and Clinical Study Reports (CSR)

Contribute to the execution and oversight of the feasibility process including the development of the site list

Participate in the set-up of study vendors including development of process flow, scopes of work, and budget review

For clinical logistics managed by the company, contribute to the overall study drug management including management (if applicable) of reference product, pre-medications, and other supportive medications / devices. For outsourced clinical logistics, contributes, in collaboration with the CRO, for the overall study drug management including management (if applicable) of reference product, pre-medications, and other supportive medications

Support global recruitment forecasting, global enrolment, and any recruitment enhancement initiatives

In partnership with the CRO, help organize investigator meetings and study training (eg, CRA training)

Contribute to inspection readiness activities (eg, TMF review, storyboard generation)

Supports internal audit and regulatory agency inspection readiness activities (eg, TMF review)

Supports / Leads the GCST, ensure operational consistency and standards across all clinical studies within a biosimilar program

Identification and resolution of cross-functional study / program issues within a biosimilar program or escalated from the CRO

Ensure timelines and deliverables are communicated cross functionally and at the CRO

Communicate study status to management

Contribute to development and maintenance of policies, SOPs, and associated documents

Represent the function by contributing to initiatives for the continuous improvement of clinical study execution

Day-to-day oversight of study start up / execution / close out activities in partnership with CRO and third-party suppliers

Along with the CRO, study-related documents, plans, site lists and timelines

Presentations to management and external audiences (when appropriate)

Recommendations for process improvement initiatives Basic Qualifications

Bachelor’s degree & 5 years of directly related experience OR

Master’s degree & 3 years of directly related experience OR

Doctorate degree & 2 years of directly related experience

Experience with oversight of clinical research organizations (CROs)

Experience in leading cross-functional teams Preferred Qualifications

7-9 years work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

Experience in oversight of outside vendors (CROs, central labs, etc) Knowledge

Knowledge of relevant therapeutic or product area

Clinical research experience obtained working on industry-sponsored global clinical trials

Excellent oral and written communication skills

Proven ability to lead, manage, and motivate others in a complex, multi-functional environment

Experience working in a global, matrix organization on global clinical development programs

Knowledge to represent and evaluate strategies for clinical development and to critically evaluate outside expert advice

Broad knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements / guidelines

Solid understanding of Biopharmaceutical / Healthcare Compliance

Proven ability to anticipate and resolve problems

Excellent interpersonal and organizational skills

Professional collaboration and leadership skills

Experience anticipating and resolving problems

Experience writing and presenting clearly on scientific and clinical issues

Experience collaborating and leading cross-functional teams Key Competencies

Team leadership

Strong written and oral communication

Flexibility

Initiative

Problem solving

Project management

People management

Decision making

Scientific / technical excellence