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Senior Manager, Study Management & Data Analytics

Location London, United Kingdom

Job Title:

Senior Manager

Department / Cost Center:

Global Medical Affairs (GMAF) Study Management and Data Analytics (SMDA)

Reports to (Job Title):

Director, SMDA

Job Code:

Location:

London

Date Prepared:

26 July 2018

Full-Time     Part-Time

Regular     Temporary

OVERVIEW:

BioMarin Global Medical Affairs Study Management and Data Analytics

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.

BioMarin Global Medical Affairs (GMAF) offers scientific and clinical expertise to post-marketing products through the direction and planning of medical communications, support of education and research, liaising with the medical community, response to incoming inquiries about Medical Affairs products and trials, and leadership of the execution of Medical Affairs trials.

Within BioMarin GMAF, the SMDA group is responsible for managing the strategy, execution, and analytics behind BioMarin’s studies, ensuring efficient, comprehensive, and compliant data collection to support BioMarin products.

SUMMARY DESCRIPTION

The Sr. Manager position is an early leadership role within GMAF SMDA focusing on developing strategic management skills across assigned trial(s). The Sr. Manager is responsible for trial(s) of increasing complexity and strategic importance and may lead departmental process improvement initiatives. The Sr. Manager is refining skills related to the management and oversight of more junior staff and taking an active role in supporting their career development.

The individual in this position exhibits strategic thinking, leadership, problem solving, adaptability, drug development, therapeutic area competencies. S/he has built foundational level people management skills.

KEY RESPONSIBILITIES:

Responsibilities may include, but are not limited to:

Vendor Management

  • Responsible for vendor selection, management and definition of performance metrics in collaboration with cross-functional business partners
  • Accountable for vendor performance and communication of expectations at the trial level

Trial Oversight and Essential Documents

  • Define the regional, country and site feasibility selection strategy
  • Accountable for the final review of the site level documentation and approval for site activation
  • Accountable for the development and management of detailed timelines for assigned trial(s)
  • Accountable for product forecasting across all supply chain activities, including shipment and reconciliation
  • Facilitate short and long term planning for assigned trial(s)
  • Approve the study-level plans, including the monitoring plan
  • Participate in the writing of study documents, including but not limited to protocols, informed consent document (ICD) form templates, regulatory reports, statistical analysis plans and study reports
  • Develop and manage the budget, including tracking monthly spend against planned, and provide GMAF SMDA leadership with updates for assigned trials(s)
  • Facilitate and manage study team meetings, including review and approval of agendas and minutes and distribution of study updates within team
  • Collaborate with the Medical Directors and/or Medical Science Liaisons to support site and/or Ethics Committee questions about assigned trial(s)
  • Responsible for trial master file (TMF) activities including establishing the TMF plan, managing the reconciliation process, and providing study-level content for filing into the TMF

Metrics, Data Collection, and Data Quality

  • Accountable for the development and utilization of management reporting tools for efficient trial execution
  • Responsible for participating in the design of data review tools, review of data quality review reports by assigned Study Team members, and resolution of identified issues
  • Collaborate with pharmacovigilance on the reconciliation of events in the clinical and safety databases

Compliance and Risk Management

  • Anticipate, identify, and collaboratively address issues that may arise at a trial level
  • Lead or participate in the development and implementation of trial level corrective and preventive action plans resulting from site audits
  • Responsible for periodic review and disposition of protocol and GCP deviations

People Management and Development

  • Oversee and provide guidance to Trial Specialists throughout the trial conduct
  • Manage performance of direct reports, including facilitating training and development


COMPETENCIES

A Senior Manager demonstrates advanced core competence in leadership, strategic thinking, and adaptability. This includes (but is not limited to):

  • Motivating and empowering employees by expecting high standards of performance while giving latitude, offering encouragement, and expressing confidence
  • Consistently reinforcing the link between individual, team and functional activities and company strategy achievement, while promoting team awareness of long term risks and mitigation plans
  • Effective handling of tense, high pressure interpersonal and team situations in a calm and diplomatic manner

The individual in this position is also expected to demonstrate advanced technical skills in drug development and therapeutic area knowledge. This includes (but is not limited to):

  • Demonstrating an understanding of clinical trial protocol objectives, scientific rationale, methodology, and procedures through the life of the clinical trial
  • Understanding the country-specific variations in regulations and guidelines that impact trial execution
  • Demonstrating an understanding of how the trials fit into BioMarin product strategy

CAREER DEVELOPMENT

BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for GMAF has been defined and is available to employees of BioMarin.


PEOPLE MANAGEMENT

The Senior Manager is expected to manage up to 2 direct reports; actual number of direct reports may vary depending on business needs

EDUCATION AND EXPERIENCE

·         BA/BSc or higher in life or health sciences preferred. Industry or relevant experience in lieu of education accepted

·         6 years of relevant experience in clinical science, clinical trial or site management, medical affairs, and/or drug development

·         2 or more years of line management experience preferred

WORK ENVIRONMENT / PHYSICAL DEMANDS / TRAVEL

International travel (approximately up to 25%) required.

EQUIPMENT

Computer work utilizing common business software programs and hardware solutions.

CONTACTS

Internal: Clinical Operations, Pipeline Commercialization, Market Access, Medical Communications, Regulatory Affairs, Patient Advocacy, Medical Directors and Medical Science Liaisons, Medical Information, Legal, Corporate Ethics & Compliance, Corporate Communications, Pharmacovigilance, Biometrics, Development Sciences Quality (DSQ), Business Operations

External: Clinical Trial Site Staff, vendors and suppliers

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London

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