Associate Clinical Country And Site Lead (Field Milano

Associate Clinical Country And Site Lead (Field
Milano
Lombardia, Milano

Job Description

This is a field based country/regionally aligned role, strategically focused on providing key local operational expertise to country and regional level clinical development strategy, enable local partnerships that enhance customer satisfaction (Internal and external), and support focused delivery and execution of the R&D pipeline.

The aCCSL (in close collaboration with or as a direct report of the CCSL, Sr. CCSL or Regional Head responsible for their country(ies)) will provide global teams with detailed local operational knowledge that will inform the overall clinical development strategy and ensure that local opportunities and needs are thoughtfully integrated into operational plans.

At the country level, the aCCSL role may be asked to provide operational direction and prioritize activities for local CCSA resources to provide a single point of contact for investigators, affiliate office staff, CRO staff, and GCO/global teams to deliver local clinical trial quality and oversight of CRO activities, with a country level focus on performance.

A key deliverable for the aCCSL will be ensuring GCO Sponsor/CRO quality oversight activities are performed as needed at the local/regional level.

aCCSLs will also serve as a site escalation point for investigator concerns, including those related to data integrity or issues which are un-resolved by the CRO, so that these may be communicated to the appropriate Biogen responsible party.

**Key Responsibilities**:

Maintain current awareness/information pertaining to local clinical knowledge of disease areas researched by Biogen, emerging standards of care, and trial related needs of clinicians in community.

Hold specific operational and scientific discussions and act as local GCO expert for the provision of country level therapeutic area, disease area, and program and study information to drive and support global operational strategy for assigned studies.

Coordinate cross functional local affiliate input as required to provide appropriate country level input into Clinical Development Plan (20%)

For assigned studies or sites manage investigator and site knowledge/relationships to inform teams of country level capabilities, interests, needs and satisfaction levels.

This would involve the development of a country level GCO investigator engagement strategy, or execution of global strategy (in collaboration with WM or local medical) to position Biogen as the company partner of choice for clinical trials.

(20%)

Support required local activities as part of agreed country and site selection process to ensure appropriate input is sought from local treating physicians and other stakeholders.

(e. g.

investigator assessment of (and feedback on) programs and protocols) (15%)

Support primary country level GCO/Biogen contact for all GCO clinical studies, leading interactions or managing CCSA interactions to ensure timely local information flow and resolution of issues as appropriate with Investigators, affiliate office staff, CRO staff, and GCO/global teams.

Understand, analyze and monitor overall Country Performance (KPIs) and support country focused activities to deliver country operational milestones (15%)

Primary country level GCO/Biogen contact accountable for strategic development and execution of country activities related to the required sponsor oversight of CRO and clinical trial activities (e. g.

SOV's, audits, and inspection support) (15%)

Support local or regional projects or other CCSM activities as a representative of their country(ies).

(5%)

**Qualifications**:

Deep understanding of cross functional drug development process and high scientific/clinical knowledge across key therapeutic areas enabling CCSL to discuss compound, development plans, and protocol endpoints with investigator site personnel

Requires strong organizational skills and leadership skills, especially project management skills, with an ability to set clear goals, align priorities and lead multiple tasks/activities

Effective working knowledge of relevant IT tools to promote virtual team working

Excellent knowledge of clinical operational activities/challenges across local geography

Proven ability to handle a high volume of tasks of varying complexity within a given timeframe and in consideration of relative priorities

Strong communication skills, including English language skill in countries where English is not the primary language

Ability to assimilate new knowledge rapidly

**Education

Science background and education (B. A or B. Sc)

**Experience

Extensive (min 5 years) experience in managing clinical trial activities, especially sponsor oversight activities in an outsourced model with CROs/vendors.